Laboratory Informatics Business Solutions. A collection of customer success stories

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1 Laboratory Informatics Business Solutions A collection of customer success stories

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3 [ TABLE OF CONTENTS ] Customer success is the true measure of product performance Waters Laboratory Informatics Software comprises a powerful suite of solutions for instrument control, scientific data management, scientific search, network integration, and compliance management to streamline analytical laboratory operations. Our Informatics solutions have helped leading pharmaceutical, environmental, food and beverage, and chemical materials organizations reduce costs, accelerate decision making, improve laboratory effectiveness, and get products to market faster. EMPOWER CHROMATOGRAPHY DATA SOFTWARE Compliant-ready software for advanced data acquisition, processing, reporting, and distribution. Provides control of Waters ACQUITY UPLC, UPC, 2 HPLC, and LC/MS systems, as well as non-waters HPLC, GC, CE, and PDA systems. A CRO Increases Competitive Advantage by Implementing Empower Chromatography Data Software...7 Becoming Paperless with an Integrated Laboratory Informatics Landscape...9 Improving Laboratory Efficiency and Reducing Compliance Efforts With a Networked Chromatography Data System Improving Quality Control and Stability Testing Efficiency with Standardized Chromatography Operations Supporting Innovation by Implementing a Lean Paperless Lab...17 Increasing Lab Efficiency by Chromatography Data System Harmonization...21 Manufacturer Reduces Vitamin QC Analysis Times by Up to 90% Multi-Vendor Instrument Control Minimizes Training and Validation Efforts with Empower Software Eliminating Chromatography Data Transfer to Spreadsheets: Reducing Errors and Improving Productivity with Custom Calculations using Empower Software Streamlining Method Validation in Pharmaceutical Product Development with Empower Software Method Validation Manager

4 [ TABLE OF CONTENTS ] NuGENESIS Platform A comprehensive compliance-ready data management and workflow solution that uniquely combines data repository, electronic laboratory notebook, sample management, laboratories inventories, and e-record lifecycle management. Improving Data Accessibility and Intellectual Property Management with NuGenesis SDMS Employing a Bioanalytical Data Management System to Increase Workflow Efficiency with NuGenesis SDMS Increasing Efficiency in Manufacturing Quality Control with NuGenesis SDMS Improving Data Management and Accessibility Across Multiple Geographies with NuGenesis SDMS...41 Informatics Technology Assists in 21 CFR 11 Compliance with NuGenesis SDMS Optimizing Efficiency with Electronic Regulatory Submissions with NuGenesis SDMS Optimizing Image Data Processing and Storage for Drug Development with NuGenesis SDMS Regional Healthcare Laboratory Automates QA/QC Process Workflow with NuGenesis ELN Automation of Doping Control Applications with NuGenesis SDMS and TargetLynx...51 MASSLYNX SOFTWARE Acquires, analyzes, and distributes Waters mass spectrometry information for comprehensive instrument control and data processing. Application Managers automate manual data processing to optimize workflow. Compound Profiling: Increasing the Throughput of Physicochemical Profiling with ProfileLynx Application Manager for MassLynx Software High-Throughput Food Safety Lab Automates QA Data Interpretation and Recordkeeping with NuGenesis SDMS and MassLynx Software ANALYTICAL WORKFLOW MANAGER Provides a single point of access for the complete handling of all an alytical laboratory tasks. Analysis Order Turnaround Times Reduced by 25% with Analytical Workflow Manager...61

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7 A CRO Increases Competitive Advantage by Implementing Empower Chromatography Data Software Client: A&M Stabtest Technology: Empower Chromatography Data Software (CDS) BACKGROUND A&M Stabtest is an independent private Contract Research Organization (CRO) that provides analytical research and development services for the pharmaceutical industry in support of drug development programs. The German-based company has headquarters in Bergheim/Cologne and a branch in Mainz. The company works for nearly all major pharmaceutical organizations with clients located primarily in Germany, Austria, Switzerland, France, and the Benelux countries. The company also supports small biotech startup companies with their services. Business Benefits As a result of the Empower Chromatography Software implementation, A&M Stabtest s scientific operations have realized a variety of highvalue benefits including: A&M Stabtest specializes in analysis and stability testing of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to ICH requirements; hence, the test results and documentation need to demonstrate expected quality. The company also provides development and product release testing; bioanalytical services; and unknowns identification. The tested samples range from small molecule drugs to biopharmaceutical therapies including proteins, peptides and antibodies. All activities and analyses adhere to GMP/GLP regulations and to demonstrate compliance, the company is routinely audited by customers and regulatory agencies. A&M Stabtest operates in a cost and time sensitive industry, consequently they continuously invest into efficiency increasing strategies like employee training and adopting the latest technologies. CHALLENGE The laboratories at both sites employ more than one hundred users and operate approximately 50 HPLC instruments manufactured by Shimadzu. Additional chromatographic equipment includes six gas chromatograph instruments from Agilent and two capillary electrophoresis instruments from Beckman and Agilent. The HPLC instruments had been running under the Shimadzu Class-VP software, which was used as a hybrid system. Only data recording was performed with the system. Chromatograms were printed on paper and integrated manually. In order to perform calculations, data were transferred manually into validated Excel sheets. The different manual activities required extensive double checks for errors and corrections when necessary. Efficiency gains, such as a time savings of 20% for the result evaluation of a project. Enhanced response times during regulatory and customer audits given the ease and speed for which information can be accessed. Reducing the waste and variability associated with the chromatographic workflow. Improved laboratory productivity. Lower project costs. Increased competitiveness. 7

8 Due to the competitiveness of the industry, A&M Stabtest sought to minimize waste and variability in the laboratory operations by reducing time-consuming and error prone manual steps in the chromatographic testing process. THE SOLUTION Platform selection The decision was made to introduce a modern, state-of-the-art Chromatographic Data System (CDS). The User s Requirements Specification (URS) document developed by the company identified required functionality, such as Part 11 technical controls, automated calculations, data management, and multi-vendor instrument support. As a result of the URS, two CDS solutions were considered, Waters Empower Software and Dionex/Thermo Chromeleon. The company chose Empower because it satisfied their functionality requirements and provided an intuitive/professional user interface, as well as a broad range of multi-vendor instrument drivers (including those for Shimadzu). Interfaces were built through partnerships with the instrument manufacturers to ensure reliability and future upgrade paths. Empower s market leading position, reputation for compliance-ready features, and continuous product improvement solidified the decision. Regulatory compliance Because A&M Stabtest must comply with regulatory safeguards and demonstrate this to both customers and government agencies, Empower Software functionalities that help facilitate regulatory compliance are of tremendous value to the company. The data traceability provided by Empower s audit trails allows staff to easily locate information during routine audits. Because speed of retrieval is so critical, the ability to separate audit trail information by project, method, etc., was considered a key feature. System deployment Today Empower is implemented in a Citrix environment with a server at each of the two sites to provide greater system performance analysts can access either Empower server as needed to share information. Advantages of operating under a Citrix environment include easy deployment of Empower clients on PC hardware of differing specifications and streamlined software validation, since only the Empower and Citrix servers require validation. Empower Software controls all chromatographic instruments at both sites including data collection, chromatographic peak integration, calculations and evaluations, and results review and approval. A&M Stabtest opted for the integrated System Suitability Testing option that allows for direct integration of their results into reports manual interaction is no longer required for these steps. Raw data, reports, and audit trails can easily be accessed within Empower, which is very convenient during routine audits. Waters assisted A&M Stabtest with the System Validation by performing the Installation and Operation Qualification (IQ/OQ). Performance Qualification was done by A&M Stabtest s staff. Concurrent with the validation efforts, all end users and power users were trained by Waters in a test environment to ensure that they could take full advantage of the Empower production system. With the validated production system in place and system training for staff completed, A&M Stabtest was able to switch from their legacy system to the new CDS literally overnight. Waters is a registered tradermark of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Produced in the U.S.A. July EN IH-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

9 Becoming Paperless with an Integrated Laboratory Informatics Landscape Client: Pharmaceutical Division of a Global Healthcare Organization Technology: Empower Chromatography Data Software and NuGenesis SDMS Software BACKGROUND The pharmaceutical division of a global healthcare organization has a comprehensive distribution network along with major production facilities in Europe, North America, Latin America, and Asia-Pacific. The QC laboratories at one of the company s large Active Pharmaceutical Ingredients (API) production sites in Europe utilize more than 100 chromatographic instruments manufactured by multiple vendors. Most of the chromatographic operation was controlled by Empower Chromatography Data Software (CDS), but a second CDS solution was used for some of the instruments. Their sample workflow was managed by Waters legacy Q-DIS/QM, a classical Laboratory Information Management System (LIMS), and the weighing process was supported by Balance View, a third independent system. Costs for the entire solution were recouped in less than 12 months and analysis processes are more than 50% faster than before. CHALLENGE Although the existing system architecture managed daily chromatographic activities adequately, integration of these platforms was lacking. As a result, laboratory operations were still dominated by paper processes. Utilizing paper for information exchange was identified as a significant source of waste and variability, e.g., handling paper documentation was very time-consuming and the related manual steps were prone to errors. Additionally, archiving the analytical raw data on paper added significant cost overhead to their laboratory services. For example, a chromatographic sequence that consisted of 20 samples would equate to the storage of a 50 to 60 page report. 9

10 Since their laboratory operations adhere to GxP regulations, customer and regulatory agency audits are a routine part of business. However, retrieving results and data stored on paper was a very laborious process. For example, the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) or FDA regulatory audits, required significant preparation time for structuring paper data, photocopying the relevant documents and cross-checking. Additionally, customers throughout the company s distribution channels would occasionally request information during root cause investigations, which would necessitate expending significant effort to locate and retrieve paper records. To establish a more automated data flow along with enhanced data management integrity, the client sought to achieve a fully integrated laboratory informatics landscape. THE SOLUTION Standardizing on a single CDS The first step towards comprehensive integration was to standardize on a CDS - Empower Software was chosen for this purpose. The advantages of Empower identified by the client include: Continuous product improvements Ability to run under technologies like Citrix Comprehensive Application Programming Interface (API) for information exchange between external systems Full scalability so it can be extended as needed. Previous experience with Empower Software in the client s corporate headquarters laboratories further solidified its selection as the single CDS solution. Empower now controls all chromatographic instruments (over 100) and supports 80 to 90 users at the production site. A single data repository Although Empower provides comprehensive management of chromatographic data, the client desired an additional solution capable of managing information from a wide variety of analytical techniques. Waters NuGenesis Scientific Data Management System (SDMS) was introduced into the laboratory to meet these needs. NuGenesis SDMS was implemented to capture all printed reports for both chromatographic and non-chromatographic results so that all reports would reside in a single compliance-ready and searchable data repository. The benefits of a single repository for reports include a common place for review and approval; easier retrieval of during an audit; and the ability to summarize and send reports to other systems such as LIMS by making using of the API. A paperless information workflow After the adoption of a single CDS for chromatography workflows and an SDMS for all testing reports, it was possible to integrate the laboratory information workflow together electronically. Work lists are created within the LIMS and transferred into an internally developed database. The weighing system transfers the weights from the balances into the same database where the weights are included into the work lists. The relevant data is consolidated into the work lists and then transferred into the sample sets of Empower Software. After performing the tests and calculations within Empower, the reports are generated by Empower and printed into NuGenesis SDMS where they can easily be accessed. The electronic signature workflow includes two checks by different individuals and is fully supported by NuGenesis SDMS. The results are displayed again before eventually being transferred to the LIMS. This entire process, which includes an audit trail, is done without paper or manual steps, thereby reducing time and errors. Hence, NuGenesis SDMS works as a central data repository where all chromatographic and related data are securely stored and can easily be retrieved and accessed. Result reports captured by NuGenesis SDMS also appear exactly as they had in paper, facilitating a high level of acceptance. 10

11 Electronic data retrieval When customers request information about certain batches they can now retrieve it themselves within the system based on the ID number. Granting customers access to data within NuGenesis SDMS can be done confidently access levels allow them to see only what they have permission to use. An additional benefit of electronic searching within the SDMS data repository is that the time required to prepare documentation for audits is almost zero. Data can be retrieved on short notice independently of record age. Data can be accessed by relevant search terms (i.e. metadata), and printed out for the auditor. In total, this takes only ten minutes (instead of days), which demonstrates to auditors that data management is effective and compliant. BUSINESS BENEFITS Adoption of Empower and NuGenesis SDMS as the standard CDS and SDMS solutions (and integration with the LIMS and sample weighing system) have allowed the company to transition to a greater than 90% paperless process in the chromatographic portion of laboratory operations for API batch release. This has led to a number of significant business benefits, including: Increased compliance Reduced errors Increased data security Improved data sharing Streamlined workflow Increased efficiency Significant cost savings (time, storage space, paper) Measurements performed after project completion have demonstrated that costs for the entire solution were recouped in less than 12 months and analysis processes are more than 50% faster than before. The new paperless lab is an important step towards meeting the company s first time-right culture. Waters and NuGenesis are registered trademarks of Waters Corporation. Empower, Q-DIS/QM, and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Produced in the U.S.A. June EN LB-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

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13 Improving Laboratory Efficiency and Reducing Compliance Efforts With a Networked Chromatography Data System Client: Erregierre Technology: Empower Chromatography Data Software (CDS) BACKGROUND Erregierre is a leading international manufacturer of active ingredients for the pharmaceutical and generics industries. The company has two cgmp manufacturing sites in Italy and includes a Research and Development organization that enables Erregierre to provide fast-track process development and a high level of service in custom synthesis. The products include cardiovascular, central nervous system disease, antifungal, antiinflammatory, gastrointestinal, anti-allergic, and expectorant areas. The broad area of products demand about thirty different synthesis reaction categories, which require high flexibility in the production process, as well as in the accompanying quality control testing and review. Erregierre serves international markets requiring compliance with FDA and EMEA regulations; hence, the business and laboratories must strictly adhere to GxP regulations. CHALLENGE The main site in San Paolo d Argon includes a Quality Control and an Analytical Development laboratory with 20 HPLC and UPLC instruments and nine users. The site in Sovere has a Quality Control lab where three people work with five HPLC instruments. All of the liquid chromatographic instruments were manufactured by Waters and were controlled by separate Empower personal workstations. The laboratory challenge centered on supporting quality testing for a large variety of products with differing production timetables. Chromatography testing on different projects often required the development and utilization of different separation methods; however, reliance upon un-networked personal workstation chromatographic systems meant that it was necessary to manually maintain projects and methods for each of the 25 individual instruments. Hence, the ideal solution to avoid the redundant manual work was to convert the isolated Empower personal workstations into a single networked Chromatographic Data System (CDS) so that developed methods were available on appropriate HPLC and UPLC instruments. Business Benefits With the migration to the Waters Empower CDS network and by using the option of selfdirected software qualification, Erregierre has been able to increase their productivity, improve regulatory compliance adherence, and reduce costs. Key benefits include: Increased efficiency in method creation and maintenance. Cost savings of 50,000 Euros per year. Reduced qualification and validation efforts by 20%. Increased regulatory compliance adherence. Increased data security. 13

14 Backing up chromatographic data represented an additional challenge because utilizing isolated personal workstations meant that the backups had to be done manually by saving data on CDs or the Intranet. This process was tedious and there was no guarantee that all data were securely stored. Working as a Contract Manufacturing Organization (CMO) in an international market, Erregierre is subject to audits and inspections by regulatory agencies and customers on a regular basis. Customer audits require that the laboratories spend approximately one week per month focused on inspection and related activities, such as preparation. While this is a necessary part of doing business for a CMO, inspection activities are time-consuming and considered non-value added with regards to laboratory productivity. THE SOLUTION The decision was made to migrate from Empower personal workstations to an Empower CDS network because the functionalities of the network solution are suitable for Erregierre s chromatographic quality testing application and regulatory compliance requirements. They were also satisfied with the Waters unique range of service offerings, including qualification for HPLC instrumentation. Tremendous efficiency gains have been achieved for the chromatographic method development by using Empower as a single CDS network solution. Once a method is created it can now be used by all of the compatible chromatographic systems in service, which has simplified their activities and increased productivity. Compliance efforts have been significantly reduced because now only one network CDS solution requires validation versus the 25 separate personal workstations that were required prior to the migration. An additional observation has been made during regulatory audits. The backup of the chromatographic data is now done automatically from the individual client systems to the Empower server. This automation of the process not only saves time but has also increased data security. Erregierre s qualification and validation efforts have been reduced by 20%. After the implementation of the Empower CDS network, Erregierre took an additional step to improve the lab efficiency. Waters Global Services provided maintenance and qualification of the chromatographic software and system. After deployment of the Empower CDS network, the staff received additional training by Waters on performing periodical qualifications themselves by using the Automated Qualification Tool (AQT). AQT is an electronic tool for Empower that fully automates and simplifies the qualification process for Waters chromatography and electronic data management systems. With this training Erregierre became selfsufficient in their CDS qualification activities. They now perform the tests four times a year, whereas previously they had only performed qualification once per year. The time effort has remained the same, but now they have the opportunity to update and cover more aspects of the system. Today Waters is still performing the maintenance of the system, but by using the self-directed AQT, Erregierre is now able to qualify more systems in a more complete way, which has led to time savings and increased confidence at the same time. Additionally, they were able to achieve a cost savings of 50,000 Euros per year. Waters and UPLC are registered trademarks of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Produced in the U.S.A. July EN IH-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

15 Improving Quality Control and Stability Testing Efficiency with Standardized Chromatography Operations Client: Napp Pharmaceutical Group Technology: Empower Chromatography Data Software (CDS) BACKGROUND UK-based Napp Pharmaceutical Group is part of a worldwide association of independent companies. The company manufactures and markets innovative products in the areas of oncology, respiratory, and pain management with analgesia being their largest therapeutic area. One of Napp Pharmaceuticals core values is innovation, which defines behaviors and decisions within the organization and therefore drives strategies in the laboratory and informatics environment. At the site in Cambridge, the Quality Control (QC) and Stability laboratories perform the required testing of raw materials, intermediates, and final release. A total of 22 people are tasked with release and shelf life stability testing. The two laboratories are equipped with 54 chromatographic instruments from multiple vendors where 34 of the 54 systems consist of dissolution baths. The chromatographic data system (CDS) used in the two labs is considered vital for achieving release of the products to market and therefore a key element in ensuring success of the entire organization. CHALLENGE The difficulties in managing and efficiently using different chromatography data systems for chromatography and dissolution represented the largest challenge for the laboratories. Further adding to the complexity of operating separate CDS solutions, the laboratory s on-going data generation started to exceed the limits of the existing file-based system data management process. Besides the data management challenges, the use of Excel for calculations and reporting was an additional source of waste and variability in laboratory workflows. For example, manual steps in documentation workflows provided the opportunity for errors due to incorrect data transcriptions. Furthermore, managers sometimes interrupted analysts during testing to request access to reports. Empower Software provides a single compliant-ready CDS solution to improve data management, boost laboratory productivity, and reduce compliance risk. In recent years, Napp Pharmaceuticals success in the marketplace has translated into greater product demand, which in turn led to the need for more sample testing and reduced result turnaround times. Any delays in testing translated into delays in product releases thus directly impacting revenue. Since chromatographic testing was recognized as vital for the product release process, management determined 15

16 that a single compliant-ready CDS solution was required to improve data management, boost laboratory productivity, and reduce compliance risk. In order to deliver a single compliant-ready CDS solution for the laboratory operations of Napp Pharmaceuticals, the IT department developed a plan to implement a commercial off-the-shelf software (COTS) package. The ideal solution would standardize chromatography operations on a single comprehensive CDS solution that included integrated data capture, analysis (including automated calculations), and reporting. For a forward-looking company such as Napp Pharmaceuticals, the new CDS system should not only satisfy the needs of today, but also serve as a platform for the needs of future business growth. THE SOLUTION A dedicated team of four analysts was assigned to the CDS implementation project. During the six months analysis phase, the team identified data security and integrity as key aspects of the project. Armed with vendor selection criteria, the team chose Waters Empower Chromatography Software as their new CDS standard. Empower was identified as a complete solution for data capture, data analysis (with automated calculations), and flexible reporting in one platform. As future workflow needs arise, Empower offers a large variety of add-on options such as Data Guard for database replication and Enterprise Data Manager (EDM) for archiving and restoring Empower projects. With the comprehensive reporting capabilities of Empower, the team was able to replace other reporting tools, including Excel. Managers now have better access to critical reports by logging onto Empower from their own computers without the need to stop an analyst during a testing procedure. Making use of Waters train-the-trainer concept, the project team has designed custom training for their colleagues to fit the workflows that analysts perform routinely. An additional advantage of Empower is its advanced technology and the fact that it is based on an Oracle database. It is considered a complete but continuously evolving solution and therefore a sound investment for the future. The selection process was weighted heavily on the capabilities of the product, but the team also valued the culture of innovation prevalent at Waters one which aligned well with Napp Pharmaceuticals own culture. BUSINESS BENEFITS Standardizing on Empower Software has enabled Napp Pharmaceuticals QC and Stability laboratories to increase sample throughput for product release. At the same time, it provides a foundation for future chromatographic data handling needs, enabling innovation one of the core values of this organization. Benefits include: Easier sharing of data between the labs Improved communication Removal of transcription errors Easier access to information Reduced errors because of a smoother and undisturbed workflow Reduced bottlenecks in the lab workflow Increased sample throughput without compromising on release times Flexibility in staff allocation Reduced training costs Waters is a registered trademark of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Produced in the U.S.A. April EN LL-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

17 Supporting Innovation by Implementing a Lean Paperless Lab Client: Chiesi Ltd. Technologies: NuGenesis SDMS, NuGenesis ELN, Empower 3 CDS, ACQUITY UPLC background Chiesi Farmaceutici is a privately owned international research and strategic innovation focused company in the Pharmaceutical sector that develops and markets products in the respiratory, cardiovascular and musculoskeletal therapeutic areas. Part of corporate R&D, Chiesi Ltd. is a technology research laboratory in Chippenham, UK that became fully functional in Chiesi Ltd. has initiated cutting-edge research in the field of inhalation delivery, with a special focus on pressurized systems. The aim is to leverage and broaden Chiesi s technology capabilities and to find innovative ways to deliver drugs to the lungs. In order to remain at the forefront of inhalation delivery technology, Chiesi is constantly examining new and existing technologies with a view of enhancing the performance of current and future pipelines. Chiesi wanted to speed up and automate activities, such as processing, transcription, and crosschecking of data, in order to provide a more rapid and reliable information system that allows innovation and interpretation of data to take priority. challenge Chiesi s Technology Research laboratory was created de novo with a long-term vision of enabling innovation, while taking full control of all data without the need for role segregation and specialist input. The entire laboratory staff of 12 people possess flexible skill sets that allow them to run all laboratory equipment. Hence, every aspect of the laboratory is designed to support science and innovation and minimize any non-value added activities. Every aspect of the laboratory is designed to support science and innovation. Chiesi s Technology Research Laboratory, Chippenham, UK 17

18 The laboratory was designed around the concept of a paperless system for data capture, retrieval, and archive. An electronic solution was sought to provide an alternative to paper-based processes and disparate databases, which many of Chiesi s users had experienced at previous companies. Their aim was to speed up and automate activities, such as processing, transcription and cross-checking of data, in order to provide a more rapid and reliable information system that allowed innovation and interpretation of data to take priority. Based on user requirements, data retrieval and collaboration were two compulsory key functionalities. Hence, from a technology perspective, they desired a solution that utilized a relational database with a centralized server in order to facilitate easily storage and location of data. Another aspect was the compatibility of the proposed software with their instrument hardware. The research laboratory simultaneously acquired two AQUITY UPLC systems from Waters, and several analytical balances from METTLER TOLEDO, and had recently added Sartorius. Hence, these analytical instruments needed to interface with their new software solution. the solution Besides fulfilling the technical requirements, Chiesi s purchasing decisions were driven by the capability of the software and instrumentation solutions to streamline and simplify their laboratory based processes. The demonstration phase of the instrument and software solution confirmed this and built confidence within the team. In order to achieve a paperless lab and to eliminate all non-value added manual and paper based steps in the laboratory, they selected the complete Laboratory Informatics solution from Waters, that included Empower CDS (Chromatographic Data Software), NuGenesis SDMS (Scientific Data Management System), and NuGenesis ELN (Electronic Laboratory Notebook). Two ACQUITY UPLC systems with ACQUITY SQD (single quadrupole MS detection) running under Empower were implemented. Each of the systems is equipped with Sample Organizer, Binary Solvent Manager, Sample Manager, Column Manager, PDA Detector and SQD. On one of the systems, a CoronaUltra RS for charged aerosol detection was utilized, that is also controlled by Empower. In addition to the comprehensive multi-vendor instrument control provided by Empower, other key functionalities of the networked Empower software are the custom fields and custom calculations that allow Chiesi Ltd to eliminate isolated spreadsheets for any CDS related calculations. For laboratory data management, NuGenesis SDMS is interfaced with all instruments in the laboratory, including UPLC, balances etc. Although Empower is capable of managing chromatography data, it was decided that all laboratory data should reside in a single data repository. Hence, data and reports from Empower as well as all results generated by any other instrument are automatically captured into NuGenesis SDMS. Additionally, all scientific documentation created internally or by external collaborators is securely stored in NuGenesis SDMS. This includes reports and even scanned drawings. The automatic metadata extraction capability enables the easy retrieval of any information for collaboration. The creation of electronic documents plays a major role in the paperless environment. The potentially time-consuming process of searching for data and manually transcribing it has been replaced by automatic import of information from the NuGenesis SDMS repository into NuGenesis ELN reports. Even though the Chippenham technology research centre does not work under GxP regulations, reviews/approvals and double signatures are an integral part of their data system the ability to verify continuous processes, concept development, and project progression is essential for intellectual property protection. The signature process is fully integrated into the electronic workflow to demonstrate the integrity of the data. Every member of the staff was trained by Waters: this was identified as the most efficient method to cross-train the entire team. Hence, with everyone equally trained on all equipment and software, workflow bottlenecks were eliminated. Shortly following training, the staff confidently designed custom fields in the Empower CDS and templates for documentation in NuGenesis ELN as a result, the team was able to utilize the solutions within a short timescale. 18

19 business benefits The main goal of implementing a paperless lab by utilizing Waters solutions was to prioritize innovation activities at Chiesi Ltd. Key benefits include: With UPLC and Empower, an example run time was reduced from ten minutes to one minute while solvent consumption was reduced approximately twenty-fold. By using UPLC, the lab required fewer instruments compared to traditional HPLC this translates to reductions in individual system suitability checks, maintenance, waste, and occupied lab space. Review and signature activities are performed easily and quickly within the NuGenesis system by research peers. Due to the automatic transfer of data, cross-checking has been reduced to a minimum, freeing up time for scientific tasks rather than non-scientific, time-consuming activities. Proof of scientific integrity as well as Intellectual Property protection is possible with NuGenesis ELN. Basic method development can now be completed in a few hours, entire feasibility studies in a markedly shorter length of time. Use of Empower Software not only provides Chiesi Ltd with increased efficiency and data integrity by reducing manual calculations and transcription; but also enables rapid identification of unexpected results by setting definable thresholds within Empower. Elimination of superfluous documentation tasks has contributed to very positive employee morale, keeping the turnover minimal and allowing the team to remain agile by keeping the staff number low. Creation of documents for experiments had previously been a paper-based and manual process. Entering information electronically into NuGenesis ELN templates and importing data from the NuGenesis SDMS database greatly reduced the time spent on this activity. Waters, ACQUITY UPLC, UPLC, ACQUITY, and NuGenesis are registered trademarks of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Produced in the U.S.A. September EN AO-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

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21 Increasing Lab Efficiency by Chromatography Data System Harmonization The client: A Generic Pharmaceutical Company Technology: Empower Software Background The client is engaged in the research, development, and production of generic human medicines and in R&D of biotechnology-based medicines. With a vertical integration of business units, their activities span from chemical development and production of active substances to the pharmaceutical development, manufacturing, and packaging of finished dosage forms. Products cover a large number of therapeutic areas that require complex syntheses and sophisticated dosage forms. The company manufactures and sells products in Europe, as well as in the United States, South America, Australia, and other parts of the world; hence, they must comply with regulatory requirements for the respective countries where it sells products as defined by regulatory agencies such as the FDA, EMEA, and TGA. Challenge The analytical R&D, as well as production-related laboratories in the U.S. and Europe consisted of a diverse chromatography software landscape. Most of the LC and GC instruments utilized specific workstation software from several different vendors. This required a high training effort in order to ensure that individuals made optimal use of the different systems. Due to number of software packages, keeping the different software solutions current and validated was an additional challenge. Finally, data management, such as exchanging chromatographic information was very cumbersome since data was stored on different drives, DVDs, and CDs. Additional information was contained on paper, in Microsoft Excel, Word, Access, etc. Furthermore Analytical Services was often perceived within manufacturing as the bottleneck during the batch release. The harmonization of the CDS application installations and introduction of Empower has significantly increased overall operational efficiency. the solution In 2007, the client s Analytical groups began investigating ways of increasing the efficiency of U.S. and European laboratory operations in order to do more with the same people and ultimately reduce bottlenecks during batch releases. This strategy centered on automating processes by introducing a Laboratory Information Management System (LIMS) and by harmonizing the Chromatographic Data Systems (CDS). In addition, they required that the local CDS networks running at the different sites also interface with the LIMS. 21

22 The client selected Waters Empower Chromatography Software for the CDS, since it was viewed as the industry standard that undergoes continuous improvements of both standard and add-on capabilities, such as third-party instrument control, method validation, and method development. The software s GMP compliance technical controls and ability to control a wide variety of UPLC, HPLC, and GC instruments from Waters, Agilent, and Shimadzu also weighed heavily in the decision. Also of critical importance, the application programming interface (API) allowed Empower to interface with the LabWare LIMS. An Empower client server installation was introduced as the company s standard CDS in the Analytical Research, Development, and Quality Control laboratories and was deployed as independent networks for each site. All implementations were deployed to satisfy regulatory requirements in a validated environment for development and QC. Functionalities with the largest impact from an efficiency standpoint included the integrated e-signature process and the dissolution option, which are considered necessities for a laboratory operating in a Generic Pharmaceutical company. Business benefits The harmonization of the CDS application installations and introduction of Empower Software has significantly increased overall operational efficiency. Despite a heterogeneous mix of projects in the different laboratories, their initial goal of doing more with the same people was realized and the Analytical departments experience much less pressure from their production focused customers. Benefits include: Reduced data transfer and switching of applications Reduced training and maintenance efforts Reduced validation efforts Easy exchange and availability of all chromatography-related data and information within and between the different sites Saving of paper and storage space Compliant-ready software A reduction of bottlenecks during batch release The implementations at all sites have exactly the same configuration for the regulated GxP laboratories, therefore the documentation and validation overhead is streamlined. URS, IQ, OQ, and PQ are the same at all regulated sites, which significantly reduces the overall validation time and effort. Also, the Empower Method Validation Manager (MVM) Software, which was deployed in R&D, provides additional savings in time and validation effort. Additional benefits of the Empower Software implementation include the ability for the QA department to modify Standard Operating Procedures (SOPs), so that paper reports are printed only at the very end of a completed testing procedure versus throughout testing, as had been the case previously, to increase analyst ease-of-use and align with business sustainability practices. Waters and UPLC are registered trademarks of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Produced in the U.S.A. December EN AO-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

23 Manufacturer Reduces Vitamin QC Analysis Times by Up to 90% Client: DSM Nutritional Products Technology: ACQUITY UPLC H-Class System and Empower Chromatography Software BACKGROUND DSM is a global science-based organization that is active in health, nutrition, and materials. The company, which is comprised of 11 different business units, delivers innovative solutions that improve performance in a broad range of global markets. DSM s Nutritional Products business is the world s premier nutritional ingredient manufacturer and supplier to producers of foods, beverages, and dietary supplements. Its product portfolio includes formulations for fat and water-soluble vitamins, carotenoids for coloration, and novel nutraceuticals. The Nutritional Products business operates a manufacturing site in Belvidere, New Jersey. The facility produces dry vitamin and mineral premixes, along with liquid vitamin blends that are used in a variety of food and dietary supplement products. Among other duties, the site s Quality Control laboratory is responsible for verifying the composition of finished products and generating COAs (certificates of analysis) for customers prior to shipment. Although the laboratory utilizes a variety of analytical techniques for sample analyses, it relies principally on liquid chromatography. COAs can be generated more rapidly ensuring customers have the product information they need as quickly as possible. CHALLENGE DSM operates within a highly competitive industry, where it is critical to deliver high quality products rapidly and cost effectively. Given the enormous production volume at the New Jersey site, the Quality Control laboratory must process thousands of multi-analyte samples annually to confirm that final product is within specifications. Once a customer order is placed, analyses and corresponding COAs must be completed as quickly as possible. Historically, laboratory workflow had involved running an analysis method for a single vitamin on one dedicated HPLC system a process that was less than optimal. In an effort to accelerate sample analysis turnaround time, reduce the cost of analyses, and increase overall efficiency, the laboratory sought to enhance its liquid chromatography-based capabilities. Of critical importance to the Quality Control group was that any technology implementation be in alignment with DSM s Quality vision. 23

24 THE SOLUTION To meet their technological challenges and sustainability objectives, the Quality Control group purchased three of Waters ACQUITY UPLC H-Class Systems with Photodiode Array (PDA) Detectors and Empower 2 Chromatography Software. The ACQUITY UPLC H-Class System provides the flexibility of a quaternary-based HPLC with the performance advantages of UPLC. H-Class enables users to continue running existing HPLC methods or transition to UPLC separations using integrated system tools and column kits that simplify migration. Since the implementation, the QC group has transferred finished product water and fat soluble vitamin assays from HPLC to the UPLC H-Class systems. All data acquisition and processing are performed with Empower Software. This includes creation of a standard report format to facilitate internal review by QC analysts and the use of Empower s Custom Calculations functionality to generate customer-specific COA results. The Quality for Life vision at DSM Nutritional Products focuses on developing products and partnerships where the essential values of Quality, Reliability, Traceability, and Sustainability are critical. Waters UPLC Technology and Support services align with our values, and give us the confidence that we will continue to provide the world Bright Science. Brighter Living, and remain the leader in providing nutritional solutions. I have worked with Waters Corporation for decades and found that their personnel and green technology consistently support these values and help protect our Quality for Life promise to the world. BUSINESS BENEFITS By replacing traditional HPLC with ACQUITY UPLC H-Class systems, the Quality Control laboratory at DSM s New Jersey site has realized several benefits in key areas, including: Laboratory productivity Test procedures were consolidated from multiple HPLCs to a single ACQUITY UPLC H-Class System, creating a more efficient workflow. The time to analyze seven water soluble vitamins in a single run has been reduced from 50 minutes to 5 minutes a 90% decrease. The time to analyze fat soluble vitamins (A Acetate, A Palmitate, and E Acetate) in a single run has been reduced from 30 minutes to 3 minutes a 90% decrease. The Custom Calculations and reporting capabilities of Empower Software help to streamline data processing and review. HPLC analysis methods can be rapidly transferred to UPLC. Lab personnel were able to master the use of UPLC H-Class and Empower Software quickly and easily. The group s senior scientist, who has used a variety of chromatography software packages, indicated that Empower was the most intuitive software out there. Customer satisfaction COAs can be generated more rapidly, ensuring that customers have the product information they need as quickly as possible. Green operations Solvent use for liquid chromatography analyses has decreased by approximately 70 to 80%; this supports the company s sustainability mission, and helps reduce sample analysis costs. Tim Wells, Director of Quality, North America Waters, ACQUITY UPLC, and UPLC are registered trademarks of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Printed in the U.S.A. July EN LL-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

25 Multi-Vendor Instrument Control Minimizes Training and Validation Efforts with Empower Software Client: A Global Pharmaceutical Company BACKGROUND The Analytical Research and Development group of a global pharmaceutical company is responsible for early-stage product characterization method development and validation. The laboratory is equipped with approximately 20 chromatographic systems from a variety of instrument vendors including Waters, Agilent (LC and GC), and Shimadzu. CHALLENGE Managing a large number of HPLC systems from multiple vendors can negatively impact laboratory productivity and increase operational costs. The Analytical Research & Development group must address a number of challenges in order to maximize their original instrument investment, including: Time and effort required to train analysts on multiple software packages Cost and risks associated with validating multiple software packages Traceability of analysis results back to the original instrument chromatographic conditions THE SOLUTION To provide comprehensive control over a broad range of chromatographic modules and connect them to a versatile chromatography data management tool, the customer employed Waters Empower Chromatography Data Software (CDS) for data acquisition, processing, reporting, and distribution. Empower s Open Instrument Portal (OIP) technology allows vendors to introduce instrument control without making changes to the Empower Software. Empower s integrated relational database allows the software to link to the chromatographic results with the original method parameters. Third-party HPLC and GC vendors who have leveraged the OIP technology to deploy instrument drivers for Empower include Shimadzu, Hitachi, Varian, PerkinElmer, and CTC Analytics. 25

26 BUSINESS BENEFIT Relying upon Empower Software for complete control of all chromatographic systems allowed the company to optimize the effectiveness of instrument related workflow. High-impact benefits for both the laboratory and organization include: Minimizing the training required for chemists to efficiently operate chromatographic software that controls existing HPLC and GC systems by standardizing on Empower. Eliminating multiple chromatographic software packages that would require additional training and validation. Avoiding the new technology implementation and validation costs that would be incurred if the chromatography software only supported a single vendor s instrument. The ability to apply Empower s unique compliant-ready tools to all instruments and provide a comprehensive audit trail with traceability back to the original instrument method conditions, combined with advanced data security and processing capabilities. Reducing the time and effort required for analysts to confirm data traceability with Empower s integrated data collection and analysis capability. n Increasing laboratory productivity by standardizing procedures, reports, and maintenance of all chromatographic systems. Waters is a registered trademark of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

27 Eliminating Chromatography Data Transfer to Spreadsheets: Reducing Errors And Improving Productivity With Custom Calculations Using Empower Software Client: A Global Generic Pharmaceutical Company BACKGROUND The Analytical Development group of a global generic pharmaceutical company is responsible for late-stage analytical development. The group transfers a number of product characterization methods required for batch release to the Quality Control group, including those tests required for content uniformity. The laboratory is equipped with approximately 100 HPLC systems. Scientists employ Microsoft Excel spreadsheets to perform a variety of calculations with the data generated from the chromatography software. The results generated from these methods are critical, as they will ultimately determine whether or not commercialized product is released and how quickly the corresponding revenue can be realized. CHALLENGE The Analytical Development group must process large sample volumes as efficiently as possible, while generating highly accurate results. In performing the requisite chromatographic data calculations, the group faces a number of challenges including: Data transfer and data transfer verification. Transcription and calculation errors. Each scientist spends one to two hours per analysis performing calculations. Time and cost associated with software training. Costs to develop and maintain macros to perform calculations. Software and macro verification and validation. n A large number of very tedious calculations. THE SOLUTION To address the time, cost, and risk factors associated with developing testing methods for batch release, the company employed Waters Empower Chromatography Data Software (CDS) for data acquisition, management, processing, reporting, and distribution. Utilizing Empower s custom calculation functionality, the company was able to automatically process data and integrate the information within Empower Software for easy review. 27

28 BUSINESS BENEFIT With Empower Software, the company is able to perform data acquisition and analysis simultaneously in one integrated software package, thereby realizing a number of high-value benefits, including: Improved productivity by significantly reducing the time required for data transfer to Excel spreadsheets and its verification. Using predefined tolerance levels, the software can detect out of spec values and immediately halts problematic runs, saving the analysts time and reducing the cost of solvent that would be wasted if the run were to proceed to completion. Mitigating risk by reducing transcription errors. Reducing the time and effort required for analysts to confirm data traceability. Improved data integrity. Reduced time and cost required for validation. Improved overall laboratory workflow the one to two hours required per analysis to perform calculations was eliminated, allowing scientists to focus efforts in other areas of the laboratory. With streamlined methods implemented in the Quality Control group, testing is performed more rapidly, facilitating batch release. Waters is a registered trademark of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

29 Streamlining Method Validation in Pharmaceutical Product Development with Empower Software Method Validation Manager (MVM) Client: A Global Pharmaceutical Company BACKGROUND A global pharmaceutical company develops, manufactures, and markets dozens of prescription and over-the-counter drugs; the therapeutics are used to treat disease conditions, including allergies, arthritis, cancer, diabetes, depression, heart disease, and HIV. As part of its drug development and approval process, the company uses numerous analytical techniques for compound quantification, purification, and characterization, including high performance liquid chromatography (HPLC). Chromatographic method validation, the process of establishing that the HPLC method is suitable for determining identity, quality, strength, purity, and potency of drug substances and products, is a regulatory requirement. Proper execution of method validation can facilitate compliance and pave the way for commercialization. Unfortunately, the current process of validating chromatographic methods is time-consuming and prone to errors, which not only negatively impacts productivity, but can also ultimately delay the introduction of products. CHALLENGE The company s multiple research and development businesses performed method validation using a variety of tools with different capabilities that created process inefficiencies. In an effort to synchronize method validation within the R&D units and manufacturing sites, the company sought to implement an automated method validation solution that would incorporate corporate-driven, template-based standard operating procedures (SOPs) for managing validation procedures, as well as providing a secure database to store results and enhance their ability to adhere to 21 CFR Part 11 requirements. A scientist with the company s R&D division indicated that Empower MVM provides a 50% overall time savings for non-sample prep activities. Even more important than the SOP templates that would guide the method validation documentation process was the need to ensure the accuracy and traceability of data. The company wanted to enable analysts to perform all method validation calculations using the same chromatography data software (CDS) they used to capture results. This would eliminate the need to export data to a spreadsheet for calculations, and the potential for error in data transfer, and simplify their validation efforts. The company also sought to include data review and approval functionality. 29

30 THE SOLUTION The company selected Waters Empower Software Method Validation Manager (MVM) as the single, comprehensive solution to satisfy all of its method validation requirements. Empower MVM is an enterprise option for the market-leading CDS platform that addresses the limitations and bottlenecks faced in chromatographic method validation. With Empower MVM, analysts at the company now have the ability to: Incorporate established SOP parameters within the CDS software Display the status of ongoing validation studies to guide the user through the workflow Preemptively associate injection data to validation characteristics Automatically check data to confirm that each validation parameter adheres to SOP requirements Approve data at various steps in the workflow Perform all validation results and statistical calculations in Empower Perform multi-component analyses and batch processing of results Alert users to results that are out of specification Generate reports with standardized templates Empower MVM also assists the company in regulatory compliance by providing audit trails, tracking injections for each validation test, designating privileges to control user activity, and securing traceable data within the Empower 2 database. BUSINESS BENEFIT By implementing Empower MVM, the company has automated and significantly streamlined the method validation process. A number of factors have contributed to an increase in overall productivity, including: Eliminating the need to transfer data to third-party software packages for statistical calculations and reporting. Reducing transcription errors and the time spent identifying those errors. Providing inexperienced analysts with SOP templates, eliminating the need to continually refer to complex and lengthy written protocols. The ability to manage a validation study is now cooperative effort since each individual involved in the process can determine what activity has completed at any time in the workflow. A scientist with the company s global R&D division indicated that nonsample prep activities account for approximately 60% of the time consumed in a method validation study. With Empower MVM, he estimates this could be reduced to as little as 10%, representing a 50% overall time-savings, as shown in Table 1. Just as importantly, the scientist said that with Empower MVM, he is more confident that his method validation data is accurate and traceable. Validation task % Total validation time Time-savings with Empower 2 MVM Administrative Sample prep 40 0 Processing data Report Generation Total Table 1. Method validation time savings with Empower Method Validation Manager. Waters is a registered trademark of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

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33 Improving Data Accessibility And Intellectual Property Management with NuGenesis Sdms Client: Pharmaceutical Division of a Global Health Care Company BACKGROUND The pharmaceutical R&D division of a global healthcare company focuses on the development and commercialization of therapeutics used in the treatment of mental illness, neurological disorders, gastrointestinal disorders, fungal infections, allergies, and cancer. An innovator, the company has developed dozens of drugs since its inception. The company operates a number of analytical laboratories that utilize automated systems to analyze large volumes of samples for internal clients. A solution was needed to integrate a large corporate archive of critical data and make it available through one online user interface. Additionally, the solution had to integrate with their corporate global compound registry system (GCRS). Challenge To satisfy electronic data management requirements for its analytical laboratories, the customer faced a number of challenges, including: The extensive use of automated systems and robotics presented complications for automated result distribution; often, each separate well plate is a measurement for a different internal customer, and is therefore handled separately. The solution needed to integrate a large corporate archive of critical data and make it available through one online user interface. Analyses have significant relevance for intellectual property protection; all patent-relevant information had to be harvested automatically in case results that needed to be retrieved on short notice. With an open access workflow, the company needed to move from labor-intensive, LIMS-oriented laboratory practices to an open, all-electronic system for scientific data management. THE SOLUTION The customer facilitated the transition to an open access workflow by implementing a number of Waters Laboratory Informatics solutions, that included the following components: NuGenesis Scientific Data Management System (SDMS): Automatically imports disparate data generated from instruments, scientists, and outside sources into a centralized data warehouse. Information can be searched, communicated, and shared among scientists, thereby facilitating laboratory efficiency, regulatory compliance, and product development. MassLynx Software: Provides mass spectrometry data acquisition and analysis. Data processing capabilities include application managers software that assists with the acquisition of application-specific data and the conversion of that data into useful information. OpenLynx Application Manager: Provides open access, walk-up LC/MS system operation, as well as customizable batch processing to support the large amounts of data resulting from high throughput analyses. 33

34 The solution impacted a number of areas. Batch reports for LC/MS analyses The customer uses automated systems to process large volumes of samples. In many cases, the results must be extracted from individual well plates separately. This data processing requirement was addressed by utilizing the NuGenesis SDMS Print to Database functionality. Printed results (the actual content of instrument-generated reports) provided by MassLynx Software are automatically captured in a centralized database, where they are indexed, made searchable, and can be shared. Individual reports for LC/MS analyses The open access analytical laboratory s the results of LC/MS analyses directly to the originator in the form of an OpenLynx report file. If the compound must be registered, the user can use Print to Database to archive the results. For U.S. sites, all data are now automatically archived with no user discretion allowed. In addition, a template was configured to harvest all patent-relevant information from the customized OpenLynx template. Accessibility of critical data in medicinal chemistry A global project in medicinal chemistry had naming conventions for all methods. A vast amount of historical data has now been uploaded onto the NuGenesis SDMS Platform from the legacy system (almost 90,000 records on VAX/VMS). Custom templates were generated for the process of extracting critical data. Search and reporting functions within SDMS enable analytical laboratory managers to generate matrix views that correlate analytical techniques to their respective sample analysis. This task had previously been impossible on the legacy systems. Global compound registration integration The company s GCRS was integrated with NuGenesis SDMS. This integration allows for batch job synchronization between SDMS and GCRS systems, allowing management to ensure that the essential analytical data is also being archived to support a structure registration in the GCRS. BUSINESS BENEFIT The customer realized a number of benefits from their Waters Laboratory Informatics implementation including: Migration to a less labor-intensive open access laboratory environment which, in turn, helped address the challenge of staff reductions. Requests from the Patent department often arrive months after the analysis. By leveraging the tight integration between NuGenesis SDMS and Microsoft Office products, it is now possible to use an Excel spreadsheet of registry numbers to look up data in the SDMS archive. Regardless of how much time has passed, critical intellectual property information can now be accessed quickly and easily. Analytical data from third-party instrumentation have been integrated within NuGenesis SDMS, with specific fields available for critical sample information such as purity, retention time, molecular ion, analytical method files, etc. The accessibility of all analytical data has improved the flow of drug candidate information between the customer s discovery, development, production, and quality control groups. A well-connected product development lifecycle has yielded gains in efficiency and reduced the time required for commercialization. Waters and NuGenesis are registered trademarks of Waters Corporation. MassLynx, OpenLynx, Empower, and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners. Waters NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

35 Employing a Bioanalytical Data Management System to Increase Workflow Efficiency Client: A global pharmaceutical company Product: NuGenesis Scientific Data Management System (SDMS) background The client is a global health care company focused on patient needs, and they offer a range of essential health care assets. The company discovers, develops, and markets a variety of innovative therapies worldwide. Extensive research and development efforts are focused largely on health care challenges in oncology, diabetes and metabolic disorders, as well as thrombosis, internal medicine, central nervous system disorders, and vaccines. CHALLENGE A recent merger combined numerous laboratories and scientific processes, including those groups involved in bioanalysis. After the merger, the company s bioanalysis laboratories employed three different systems to manage analytical data. The systems included PerkinElmer s SQL*LIMS, ThermoFisher s Sample Manager, and Innaphase s (now ThermoFisher) Watson LIMS. The typical workflow that resulted, including sample handling and analysis documentation, proved to be less than optimal. Challenges included: Compliance management 21 CFR Part 11 compliance was inconsistent from site to site. Paper-centric legacy processes Filling out, reviewing, collating, moving, and storing paper records was very time consuming. The amount of paper generated per run has been reduced by 90% a savings of 56,000 sheets of paper at a single site. Mining information from the paper records was difficult and inefficient. Operating costs Each analytical run produced 70 to 100 sheets of paper. Annually, nearly 100,000 sheets of paper were printed and stored. In addition to streamlining workflow, it was the desire of the bioanalysis groups to significantly reduce the amount of paper generated and stored during the course of standard operations. 35

36 SOLUTION Bioanalytical data management system To reduce the volume of paper generated and increase overall workflow efficiency, the company implemented a bioanalytical data management system comprised of the following: NuGenesis SDMS With Waters NuGenesis SDMS, data from a wide variety of sources, including instruments and analysts, can be readily imported and indexed within a centralized electronic data warehouse. Once collected, this information is easily searched, communicated, and shared. All LC/MS/MS data from bioanalysis studies, including printed reports, are stored in NuGenesis SDMS. The MS systems are from multiple vendors. Peak areas and final reports are exported from NuGenesis SDMS directly into Watson LIMS. After a study is completed, all electronic data is securely archived according to GLP regulations using the electronic signature functionality of NuGenesis SDMS. The QA review process before and after Before the bioanalytical data management system: Analysts collated all paper run reports, sample logs, LIMS printouts, and final reports. Material was then physically transported to Quality Assurance (QA). QA audited the reports, and eventually provided a final signedoff report this process required a minimum of five days. After the bioanalytical data management system: The QA analyst receives a printed copy of the report and audits against electronic records and the report from Watson LIMS to ensure data transfer has been performed correctly. Approvals are done electronically using the built-in function of NuGenesis SDMS, and no longer require handwritten signatures on paper reports. Watson LIMS A specialized, protocol-driven LIMS designed to support bioanalytical studies in drug development Watson LIMS contains all the information about the design of a study, including subjects, treatments, timings, and samples. It also contains the logistic information and bioanalysis run information, as well as the final concentrations. With NuGenesis SDMS, data from a wide variety of sources, including instruments and analysts, can be readily imported and indexed within a centralized electronic data warehouse. 36

37 BUSINESS BENEFITS The client s bioanalytical laboratories have realized significant gains in workflow efficiency, as well as cost reductions through the implementation of a bioanalytical data management system. Benefits include: Greater productivity Review steps for analyst, checker, and principal investigator have been eliminated. The reduction in QC review time has saved approximately 45-man days per year for the eightperson team. Reduced costs The amount of paper generated per run has been reduced by over 90% a savings of 56,000 sheets of paper at a single site. Validation effort By using a standard rollout/configuration, validation has been simplified, and is performed only once. Leveraging vendor validation services, as encouraged by GAMP5, has further reduced the time and effort required for validation. Compliance management The automatic capture and securing of instrument data, final reports, and LIMS data by NuGenesis SDMS have assisted the company s laboratories in meeting regulatory requirements. Waters and NuGenesis are registered trademarks of Waters Corporation. The Science of What s Possible is a trademark of Waters Corporation. All other trademarks are the property of their respective owners. NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance Waters Corporation. Produced in the U.S.A. March EN LB-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

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39 INCREASING EFFICIENCY IN MANUFACTURING QUALITY CONTROL WITH NuGENESIS SDMS Client: Waters Corporation, Liquid Chromatography Column Manufacturing Facility BACKGROUND Waters Corporation operates a liquid chromatography column manufacturing facility in Wexford, Ireland that produces over 95% of all columns sold by Waters. The department employs approximately 70 people, including six production support analysts and two chemists. Facility production volume is up to 5,000 units per week, and includes Waters Symmetry, Atlantis, XTerra, ACQUITY, and XBridge column brands. Column packing materials are supplied by another Waters manufacturing facility located in Taunton, Massachusetts. Columns are used for both Waters and third-party liquid chromatography systems, and are shipped to thousands of customers in locations around the world. CHALLENGE A critical step in the column manufacturing process is the review of outgoing customer orders prior to packaging and shipping. The reviewer s primary responsibility is to inspect product quality and associated paperwork; however, reviewers are also required to manually enter data for 14 categories of column detail information, such as efficiency, back pressure, retention time, batch number, part number, serial number, etc. In total, 56,000 manually transcribed entries are made per week a laborious, time-consuming process. In addition, all column detail data are archived on DVD s. Accessing this information for customer inquiries regarding products in use may require up to 2 hours of the analyst s time, potentially reducing productivity and increasing response time. The time for a reviewer to input product data for one 96-piece customer order has been reduced by 50%... reviewers are able to focus even more time on quality improvements. 39

40 THE SOLUTION In September 2006, the Wexford facility implemented Waters NuGenesis Scientific Data Management System (SDMS). With SDMS, data from a wide variety of sources, including instruments and analysts, can be readily imported and indexed within a centralized electronic data warehouse. Once collected, this information can easily be searched, communicated, and shared. In the Wexford application, SDMS interacts with Waters Empower Chromatography Software via its Print-to-Database functionality as reviewers print column test chromatograms, SDMS automatically catalogs and captures the pertinent information, and saves it to the database. Information on the column, including a hyperlink to the corresponding chromatogram, can be instantly retrieved anytime, from multiple geographic locations. BUSINESS BENEFIT The implementation of SDMS has afforded a number of benefits to the Wexford facility s order fulfillment workflow, including: Risk reduction The automatic capture of column detail information with SDMS has reduced the data entry error rate to nearly 0%. During the Print-to-Database operation, a template ensures that all relevant indexing information is captured for each chromatogram, thus providing automated error proofing. Greater productivity The time for a reviewer to input product data for one 96-piece customer order has been reduced by 50%. Better quality With less time required for data entry, reviewers are able to focus more time on quality improvements. Process optimization SDMS provides rapid trending of column test data. Results are instantly accessible to the Waters Taunton facility staff, which allows them to make any necessary adjustments during the packing material production process, and optimize column performance specifications. The end result is an improvement in batch-to-batch reproducibility and delivery of a consistently performing product. Enhanced collaboration Electronic storage of column performance records means that data can be easily shared between the Taunton and Wexford facilities on a 24/7 basis. n Faster customer service By simply entering a particular serial number into SDMS, an analyst has instant access to archived column QC data. Customer inquiries on column performance can be addressed immediately, which helps minimize disruptions to the customer s workflow. Waters, Symmetry, Atlantis, XTerra, ACQUITY, and NuGenesis are registered trademarks of Waters Corporation. XBridge, Empower, and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners. Waters NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance. SDMS Vision Publisher is covered under a formal Quality Management System certified by the TÜV Rheinland Group Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

41 Improving Data Management and Accessibility Across Multiple Geographies with NuGenesis Sdms Client: A Global Technology-Based Manufacturing Organization BACKGROUND The technology division of a global plastics manufacturer has several hundred employees working in six business divisions located in North America, Europe, and Asia. Like many scientific organizations, the customer found it challenging to manage, transfer, review, and report technical data and information across multiple geographic locations. CHALLENGE The technology division is comprised of product developers, platform chemists, analytical chemists, and technicians located at eight different sites worldwide. Single-point instrument data were captured electronically and stored in a LIMS; multi-point data were often stored in paper format. Reports and presentations had different storage formats and sites. Historical knowledge was difficult to access globally sometimes it was lost entirely. THE SOLUTION To address this challenge, the customer chose to implement Waters NuGenesis Scientific Data Management System (SDMS). NuGenesis SDMS automatically captures data from various applications as either raw data, or as a printed report, and builds a catalog containing metadata (data about the data). Any authorized user can access the data (chromatograms, spectra, and reports) via a web-based browser. The modular architecture of the SDMS system lends itself to customization to suit business needs. What dictates the system architecture? To minimize the impact on speed, a single server was ruled out. Operational centers in North America, Asia, and Europe were designated as sites for regional servers. Each site connects to all three servers through one interface. We found that teaming with Waters experts and good up-front planning were critical to our successful implementation. Who supports the system? There is a global help desk. A global administration team from the customer s technology function, not IT, oversees system support. What is the best way to ensure that features map to business-critical systems? Two stages of data modeling ensured that the system would meet the requirements of the user base. It was critical that the system meet user expectations at launch so that the users could see the time savings and immediate benefit. 41

42 The first data modeling stage was a big-picture analysis of how the system would function; the second stage dealt with views, privileges, SOPs, and templates. In addition, planning was necessary for LIMS interfacing and password synchronization among three servers. The customer found that one of the most valuable facets of the data modeling experience was having a Waters system engineer assist during the data modeling session. The customer found that teaming with Waters experts and good up-front planning were critical to their successful implementation. How does Waters ensure long-term system sustainability? Measuring how many documents are printed and archived per business and per site, as well as monitoring retrieval statistics allow maintenance, upgrade efforts, and refresher training to be directed to the appropriate sites and/or business units. The total number of print data records grew from 8,144 in the first full quarter after implementation to 142,000 by the end of the third quarter. Roughly 55% of those records came from migrating legacy repositories into SDMS to make them text searchable; 38% were laboratory data, and 7% included other reports and project documentation. What was the biggest lesson learned during implementation? It was important to spend several months populating the system with legacy data before rolling out the application. This enabled the customer to verify the data model, and provide a base repository supporting initial activities. Doing this made NuGenesis SDMS a tool that users wanted to use daily as soon as it was available, as opposed to being trained on a relatively empty system where they wouldn t see immediate benefits. BUSINESS BENEFIT By tracking and categorizing one week of activities into value-added categories (research, notebook documentation, and writing papers) and non-value-added categories (managing paper files, looking for data, faxing, and data), the customer determined that they could realize a 10% time savings globally by using NuGenesis SDMS. Additionally, the customer calculated that the number of paper records that could not be located after several years, and the calculated fraction of the analytical budget used to generate those data were enough together with the activity mapping to justify their investment in NuGenesis SDMS. Other benefits that resulted from the NuGenesis SDMS implementation include: Increased speed of new product introduction. Leveraging global talent and bringing new sites up to speed more quickly. Reducing transcription errors with paperless laboratories. Instant availability of multi-point data. Enabling transparent, consistent global processes. The ability to work across time zones. Avoiding work redundancy. n People locating data themselves rather than submitting a request. Implementation of a NuGenesis SDMS data repository created a paradigm shift in the way that this large, global technology-based manufacturing organization has been able to archive and communicate technical data. A solid implementation enabled the customer to reap many benefits, from cost-out productivity of streamlining processes and reducing the time spent on managing data, to sharing important information and knowledge with scientists around the world. Waters and NuGenesis are registered trademarks of Waters Corporation. The Science of What s Possible is a trademark of Waters Corporation. All other trademarks are the property of their respective owners. Waters NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

43 21 CFR PART 11 Compliance with NuGenesis SDMS Client: A Biopharmaceutical Company BACKGROUND A US-based biopharmaceutical company is engaged in the discovery, development, and commercialization of medicines used in the treatment of diabetes, obesity, and cardiovascular disease. The company is primarily focused on investigating the potential utility of new peptide hormone candidates, and has significant research and clinical expertise in metabolic medicines. They have developed a proprietary library of novel synthetic polypeptides to identify and characterize the activity of both known and unknown peptides. The company has a number of therapeutics in various stages of clinical development and is subjected to continual regulatory scrutiny. CHALLENGE To satisfy US FDA regulatory demands, the company must comply with 21 CFR Part 11 guidelines for the backup and archival of critical laboratory data. Specifically, they required a data management solution that allowed for document lock-down and revision control for Microsoft Excel spreadsheets. Their process involved manually transferring data from paper reports to Excel spreadsheets. The spreadsheets required 100% quality verification to ensure the integrity of the data. This verification process was very labor intensive and prone to transcription errors, all of which had to be identified and corrected. THE SOLUTION The company selected the Waters NuGenesis Scientific Data Management System (SDMS) for its ability to automatically import disparate data generated from instruments, scientists, and outside sources into a centralized information warehouse. With NuGenesis SDMS, data can be easily searched, communicated, and shared among scientists, thereby facilitating laboratory productivity, product development, and regulatory compliance. Waters Enterprise Software Solutions (ESS) team worked closely with the customer on all aspects of the NuGenesis SDMS application deployment. The deployment consisted of the following components: File Capture Allows any kind of file data to be automatically captured, cataloged, and secured. Print Capture Allows print data (the actual content of instrument generated reports) to be captured, indexed, and secured in high fidelity. 43

44 UNIFY templates Extracts valuable data from captured printouts for cataloging and later retrieval. Auto Extraction templates Automates search and extraction of pertinent data, and the exportation of the data to external applications for additional calculations. Application Control Manager (ACM) Provides a secure, compliant framework for using Microsoft Office applications, including Word, Excel, and PowerPoint. Waters ESS team partnered with the customer to define the requirements for the Auto Extraction templates to support Analyst and SoftMax Pro reports. This enhancement gave the company the ability to extract the maximum number of data points required into Excel. Waters coordinated the creation of the functional specifications, product development, testing, and IQ/OQ/PQ for the installation and validation testing of the Auto Extraction enhancement. Software Development Kit (SDK) For custom programming using NuGenesis SDMS functionality, such as specialized integration with legacy software. The system was configured and data modeled to support multiple File Capture and Print Capture applications types. Waters was responsible for the execution of the Installation and Operational Qualification (IQ and OQ) workbooks, which test the installation and operation of the base system. Waters also provided customized Performance Qualification (PQ) scripts that test business processes, and verify that the appropriate standard operating procedures (SOPs) are in place, to ensure that the system meets the requirements for its intended use. A driving force for implementing NuGenesis SDMS was its seamless integration with Microsoft Excel. The solution s functionality gave the company the ability to control and extract data to Excel spreadsheets with the highest confidence. BUSINESS BENEFIT This biopharmaceutical company is 21 CFR Part 11 compliant in their labs for backup, archival, and retrieval of critical clinical and pre-clinical data. With the NuGenesis SDMS solution, they have dramatically improved their ability to control validated spreadsheets. The scientists can transfer data automatically to the controlled Excel spreadsheets without requiring data quality verification. The use of Auto Extraction for Analyst and SoftMax Pro reduced turnaround time from 30 minutes per report for manual entry, to one minute for the automated solution. On average, this has reduced the time required for data entry by more than five hours per week. Now the company s quality department can perform spot audits of the data, rather than the 100% verification after manual data entry. The company plans to deploy NuGenesis SDMS in all of its labs. Application Control Manager (ACM) will be used to control validated spreadsheets. Additionally, ACM will be used to control an electronic laboratory logbook. Waters and NuGenesis are registered trademarks of Waters Corporation. The Science of What s Possible is a trademark of Waters Corporation. All other trademarks are the property of their respective owners. Waters NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

45 Optimizing Efficiency with Electronic Regulatory Submissions with NuGenesis Sdms Client: A Generic Pharmaceutical Company BACKGROUND A large generic pharmaceutical company has research, development, manufacturing, and distribution operations worldwide, including North America, South America, Europe, Asia, and Australia. The company s ongoing goal is to maximize return on investment in R&D by reducing the time required to develop and commercialize new products. A number of strategic initiatives were launched to achieve this goal, including the implementation of Waters Laboratory Informatics solutions. Waters NuGenesis Scientific Data Management System (SDMS) plays a vital role in automating scientific data entry into the company s electronic Common Technical Document (ectd), a standard electronic format for regulatory submissions. The ectd is an advanced method used by pharmaceutical companies to assemble and submit regulatory submissions to regulatory bodies around the world, including the US FDA, Health Canada, Japan s Ministry of Health, Labor and Welfare; and the European Union s European Medicines Agency. This represents a unique set of challenges for electronic record and data management. Data and records must be archived in a compliant, secure database that protects the integrity of e-records from tampering and loss throughout their relevant retention periods. CHALLENGE The company required an electronic solution that provided information management capabilities that were superior to legacy paper documentation and workflow archiving. The solution needed to address a number of key business drivers, including: Securing new product exclusivity by optimizing the regulatory submission process Responding to regulatory and industry initiatives by implementing common standards for e-submissions and e-information exchange Maximizing return on investment in R&D Reducing product development and commercialization time n Increasing productivity and efficiency while decreasing costs SDMS plays a vital role in handling scientific data entry into the company s electronic Common Technical Document (ectd) for regulatory submissions. THE SOLUTION The company selected NuGenesis SDMS as the cornerstone of its strategic initiative to establish a worldwide corporate information management, exchange, and submissions system. 45

46 Their Electronic Regulatory Submissions project, initiated in 2001, employed an integrated software solution that combined several core applications: Waters NuGenesis SDMS: Automatically imports disparate data generated from instruments and outside sources into a centralized data warehouse. Information can be searched, communicated, and shared among scientists, thereby facilitating laboratory efficiency, regulatory compliance, and product development. Broadvision One-to-One Document Management System: Provides content management of business documentation in Microsoft Office formats and XML with e-signature workflow, and integrated PDF and web publishing. n Lorenz docubridge: Combines content collected by NuGenesis SDMS and Broadvision in an ectd document for submission. The NuGenesis SDMS implementation began in early The first phase of the deployment concentrated on four North American sites and was completed in less than two years. Of primary interest to the customer was the utilization of the SDMS Print Capture technology, which captures, indexes, and secures the actual content of instrument-generated reports. The company relies on Print Capture for scientific data capture, metadata extraction, and archival from a variety of data sources, including PerkinElmer s TotalChrom chromatography software, Agilent s ChemStation and ChemStore chromatography software; LIMS, and other supporting systems. During the software integration phase, Waters Enterprise Software Solutions (ESS) group worked closely with a crossfunctional team that included the company s Corporate Regulatory Operation and IT departments. The Waters ESS team provided postdeployment business and technical support, as well as maintenance; incorporating critical feedback from the customer to ensure continuous improvement. The successful validation of key software solutions is an essential component of any major deployment. The validation for this solution consisted of two stages: first, the core applications, and second, the individual site-specific rollouts. Timelines were 7 months for the core application IQ/OQ, and 4 to 11 months for the IQ/PQ site-specific data configuration. BUSINESS BENEFIT NuGenesis SDMS now plays a vital role in handling scientific data entry into the pharmaceutical company s electronic Common Technical Document (ectd) for regulatory submissions. The ability to be the first to register and obtain approval for a new pharmaceutical product yields six months of exclusivity and significantly enhances revenue potential. Moving to an all-electronic scientific and business information management strategy that facilitates workflow for laboratory scientists making their final regulatory submissions has yielded great gains in efficiency. The availability of scientific data through NuGenesis SDMS has increased the company s productivity, and serving as a single point of access for all information regardless of geography, SDMS has helped the company substantially reduce their operational costs. Finally, in an environment of increased scrutiny by global regulatory inspectors, the company has enhanced its competitive and strategic positioning by improving its ability to readily satisfy compliance. Collectively, these benefits have allowed the customer to reduce product development and commercialization times. Waters and NuGenesis are registered trademarks of Waters Corporation. The Science of What s Possible is a trademark of Waters Corporation. All other trademarks are the property of their respective owners. Waters NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

47 Optimizing Image Data Processing and Storage for Drug Development with NuGenesis Sdms Client: A Pharmaceutical Division of a Global Health Care Company BACKGROUND A pharmaceutical subsidiary of a global healthcare company is focused on the development and commercialization of therapeutics that are used for treating mental illness, neurological disorders, gastrointestinal disorders, fungal infections, allergies, and cancer. An innovator, the company has developed dozens of drugs since its inception. To support their discovery and development efforts, the company uses a number of analytical techniques, such as multi-mode high throughput screening (HTS) in well plate microscopy systems. These systems are typically used for target identification, target validation, assay development, HTS, hit-to-lead, deep pharmacology, and ADMET analysis. The vast amount of data produced is typically generated in the form of electronic images. CHALLENGE The customer needed to support image-driven research in a medium-to-high data throughput environment. Managing the capture, storage, and retrieval of large volumes of image data can present a variety of problems for pharmaceutical organizations. Secure information storage can be cost prohibitive unless the system is well designed, and the business benefits are prioritized. Using numerous localized DVD/CD backups for data storage limits the accessibility of this valuable information, preventing full utilization of a corporate resource. The scientific image data management system deployment has revolutionized the company s ability to process and store large amounts of image data at acceptable costs. System Administrator, Global Health Care Company 47

48 THE SOLUTION The customer implemented Waters NuGenesis Scientific Data Management System (SDMS), which automatically imports disparate data generated from instruments, scientists, and outside sources into a centralized data warehouse. Information can be searched, communicated, and shared among scientists, thereby facilitating laboratory efficiency, regulatory compliance, and product development. For this implementation, the NuGenesis SDMS Platform was combined with a customized user interface and a carefully developed and tested raw data file archiving strategy. The solutions comprise a scientific image data management system (SIDMS). This SIDMS provides optimal support for working with image data from local workstations to a customized, unified workbench environment that relies on gigabit network connectivity between building blocks. Key to this successful deployment was its integration with an affordable alternative for managed storage of large quantities of images: Advanced Digital Information Corporation s (ADIC) total data lifecycle management system. With the ADIC system, data are captured from multiple operating systems that are connected to multiple devices via the storage area network. Original data files are captured and indexed by the NuGenesis SDMS automated file capture agent; SDMS provides central data management of the online and archived data. The platform s Offline Storage Manager (OSM) provides this control to an ADIC storage area network and tape library system. A customized unified workbench then facilitates the retrieval of desired files from the archive to a local workstation. This restoration service is robust and takes advantage of the high-speed network between the individual components of the solution. Because of the large volume of data, the network was upgraded to a dedicated one GB network between client computers, servers, and their offline storage systems. The SDMS Software Development Kit (SDK) was used to develop custom integration tools to interface with ADIC library software. Special functionality was included for uploading and downloading large image datasets. Iterative tests on 800 GB of data yielded a performance of 5 GB per hour net capture of file data to the ADIC library system, and 7 GB per hour net retrieval from the ADIC system to the client. Assuming a 50% uptime, the system provided capture and restore capabilities of 400 GB per week, and 600 GB per week, respectively. BUSINESS BENEFIT The scientific image data management system deployment has revolutionized the company s ability to process and store large amounts of image data at acceptable costs. The combined NuGenesis SDMS-ADIC technology can be leveraged for virtually any type of scientific data. Benefits include: Elimination of decentralized and unmanaged DVDs/CDs Added value to major investments in image acquisition and processing infrastructure Providing data from service labs to client research departments is simple and flexible n Offline image data processing, which enables the company to increase its HTS capacity, as well as its ability to gain new insights into results by reprocessing image sets The Waters NuGenesis SDMS-ADIC strategy to build a SIDMS solution has provided the customer with a unified workbench that delivers image data to the fingertips of the researcher. Robust services transparently manage the end-to-end data flows, with functional and performance tests exceeding the initial objectives of data security and throughput. Waters and NuGenesis are registered trademarks of Waters Corporation. The Science of What s Possible is a trademark of Waters Corporation. All other trademarks are the property of their respective owners. Waters NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

49 Regional Healthcare Laboratory Automates QA/QC Process Workflow with NuGenesis ELN The Client: Regional Pharmaceutical QA Laboratory, UK National Health Service BACKGROUND The West Midlands Regional Pharmaceutical Quality Assurance (QA) Laboratory, which is part of the UK National Health Services (NHS), provides pharmaceutical QA/QC advice to health care professionals within the region. It is the center for reporting and monitoring of defective purchased medicines, pharmaceutical specials, and medical devices used in pharmaceutical manufacturing and administration. The lab provides QA support and assessment to the NHS Supplies Central Division Drug Contract for purchased medicines used in primary and secondary care, as well as screening of herbal medicines for illicit active pharmaceutical ingredients. Testing and certification is carried out in the areas of piped medical gas systems and pharmaceutical clean rooms. In addition, the lab provides services for audits of unlicensed aseptic manufacturing units as pharmaceutical QA/QC services to the University Hospital Birmingham NHS Foundation Trust. When a sample arrives in the laboratory, compliance and validation analysts review the standard operating procedure (SOP) documents, and record a notebook entry with reference to the batch number. Analysts perform the necessary regulatory checks and transfer the sample to the technicians for analysis, according to the appropriate SOP. After all analyses have been completed and recorded in the notebook, the batch is signed by the validation analyst and the lab manager who oversees the analyses. The results are then transferred into a trend analysis sheet, which is presented to the releasing officer for approval. The releasing officer then enters this data in a LIMS and determines the fate of the batch. CHALLENGE The pharmaceutical QA lab has always operated with a multiple paper notebook system. The analysts spent a significant amount of time locating the paper notebooks that corresponded to a particular analysis. This logistics dilemma was exacerbated by an increasing sample load due to the inclusion of healthcare trusts from an expanded geographic area; the additional influx of samples was projected to continue into the foreseeable future. NuGenesis ELN reduced the time spent on data entry, searching, checking, and cross-checking information in manufacturing analysis by 20%. In an effort to address inefficiencies inherent to their paper notebook system, as well as their increasing workload, the customer sought to implement a structured electronic solution. The solution would be required to provide an exact 1:1 copy of their current workflow. 49

50 THE SOLUTION The Waters NuGenesis ELN is an electronic laboratory notebook that provides customers with the ability to transition from a paperbased to a more automated laboratory process that encompasses the entire scientific content lifecycle, which includes discovery, development, production, and QA/QC. NuGenesis ELN is designed to provide a seamless interface to analytical processing tools and other software programs, such as Microsoft Excel, Word, or chromatography data software (CDS), such as Waters Empower Software, used everyday in the laboratory. NuGenesis ELN allows for the automation of scientific content collection and storage while satisfying compliance requirements, including e-signatures and audit trails. In this deployment, NuGenesis ELN was scaled to process approximately 2,000 analysis orders per year using approximately 600 different substance templates. The initial deployment concentrated on template development, and has been expanded to include regional sample templates, as well as experimental data harvesting. Templates were created in NuGenesis ELN for three primary groups of analyzed substances: raw materials, finished products, and ad hoc samples. The laboratory tests approximately 150 different raw materials and approximately 150 finished products; it then assigns an individual template for each product according to SOPs and working instructions. The technicians are provided with a fixed identification code and a signed SOP document for each raw material. This signed SOP is available within the respective raw material analysis templates in NuGenesis ELN as a PDF document. Excel template objects can be locked, so that only the required fields can be edited. The QA laboratory also makes use of trend documents for both raw materials and finished products, so that the various substances can be monitored over their entire lifetimes. This trend document is created for each product ID when the SOP is created. Results from each analysis of of a particular substance over time are copied from the Certificate of Analysis and pasted into the trend document. The trend documents are stored as separate experiments within NuGenesis ELN. BUSINESS BENEFIT Implementation of NuGenesis ELN has allowed the West Midlands Pharmaceutical QA Laboratory to realize significant gains in analyst productivity. For manufacturing analysis work, time spent searching for information was reduced by approximately one-half day per week per analyst, and the time required for checking, cross-checking, and data entry was reduced by another half day per week; this represents 20% of analyst time that can be allocated to other tasks. For regional lab studies, approximately one day per study per month was also saved. In addition to productivity gains, NuGenesis ELN has contributed to the reduction of calculation errors by automating the conversion to validated data entry templates. NuGenesis ELN has also eased the burden of compliance by providing the ability to immediately comply with increased regulatory pressure to track out-ofspecification results and associated exception reports. Other NuGenesis ELN functionalities of particular utility to the lab include integrated messaging and data viewing. The integrated messaging system, which notifies users of upcoming action items and related record changes, proved very useful for controlling analytical workflow. Integrated data viewing has allowed the customer to visualize data (in a single interface) that was produced from an extensive instrument park that includes Thermo Nicolet FTIR, Thermo Unicam UV, Waters Alliance HPLC, Agilent HP1100, Finnigan LC/MS, and TotalChrom GC. Waters, NuGenesis, and Alliance are registered trademarks of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners. NuGenesis ELN is covered under a formal Quality Management System certified by the TÜV Rheinland Group. Waters NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

51 Automation of Doping Control Applications with NuGenesis Sdms And TargetLynx Client: Karolinska University Hospital, Sweden BACKGROUND The Doping Control Lab of the Karolinska University Hospital in Stockholm, Sweden is one of 33 doping control labs worldwide accredited by the World Anti-Doping Agency (WADA). The lab s nine chemists and lab technicians analyze approximately 7,500 samples annually, including 4,717 athlete samples (compared to 183,337 samples worldwide). 87 positive samples were found at the Karolinska lab in 2006 (3,909 worldwide), using hyphenated chromatographic techniques such as GC/MS, GC/NPD, and LC/MS/MS. Karolinska s Doping Control Lab receives samples from a variety of customers, including the Swedish Sports Confederation, WADA, and other International sports confederations, as well as from correctional institutions and public health services. The Doping Laboratory is primarily financed by payments for analyses performed; therefore the more samples that are run and results secured, the more income is generated to finance research and extended testing. CHALLENGE WADA s World Anti-Doping Code provides an internationally standardized list of prohibited substances for athletes, both in and out of competition, as well as specific regulations for particular sports disciplines. A laboratory s work is assessed by WADA on the basis of a proficiency testing program, which must be successfully completed if the laboratory is to retain its status as an official doping control laboratory. The Karolinska lab focuses specifically on testing for the 44 diuretics and other masking agents, as well as the 58 stimulants listed in the WADA code. In the future, they are planning to add tests for narcotics and beta-blockers to their spectrum. Tests for diuretics and narcotics have been conducted using GC/MS, involving complex sample preparation with hydrolyzation, extraction, and derivatization. Stimulant tests using GC/NPD involve similarly complex preparation steps. Increasing regulatory pressure and introduction of new technologies have driven up the number of samples analyzed and increased the quality of data produced. Managing information and controlling the flow of data were major challenges. Enhancing the lab s information and knowledge management processes is an area where Waters Laboratory Informatics has played a crucial role. THE SOLUTION New analytical methods have been introduced using LC/MS/MS. The sample preparation for this method is now significantly easier, since a diluted urine sample can be directly injected into the instrument with an internal standard added. This allows for more samples to be prepared and analyzed. The solution chosen by the Karolinska Doping Control Lab is the Waters ACQUITY UPLC System with a BEH Shield RP18 column, 50 x 2 mm, 1.7 µm, with a flow rate of 0.4 ml/min (MeOH/NH 4 OAc 10 mm gradient, 6 min). A QC sample is run at every 12 th injection; water and urine are used as blanks. For detection, Waters Quattro Premier XE tandem quadrupole mass spectrometer is operated in MRM mode. The instruments are controlled by Waters MassLynx Software, with processing and reporting done using the TargetLynx Application Manager. TargetLynx is specifically designed for quantitation and specific analyte confirmation, and it streamlines and automates the analysis of samples. All raw instrument data are automatically and securely captured and stored within Waters NuGenesis Scientific Data Management System (SDMS). 51

52 The Karolinska lab has found that with the UPLC System, they can now screen up to 105 analytes in 8 minutes, injection to injection. The hospital uses TargetLynx Application Manager to find analytes that comply with three criteria: Correct retention time Above signal-to-noise n Above concentration threshold If a positive hit of an illegal drug is detected, TargetLynx will flag this analyte. Having automated the analysis and post analysis calculations, they were still faced with the need to manually review 140 compounds per sample and determine the positive hit patterns. Today, there are more than 100 samples in each batch. This manual process is tedious and time consuming, where mistakes can easily be made. Most samples are negative (only 2.5% of samples are positive). The next step was to automate and streamline the TargetLynx report utilizing the Print Capture capabilities within NuGenesis SDMS. Analysts now print all reports into SDMS with a TargetLynx format, that includes the stimulants, ephedrines, and diuretics as individual reports. These reports are normally several hundred pages long. When analysts run the custom application provided by the Waters Enterprise Software Solutions (ESS) group, they have the choice of defining the batch number by parameters that include standards, controls, and blanks. Then all reports can be extracted from a particular batch, excluding all standards, QCs, and internal control analytes. QC results are automatically exported to their LIMS. The end result is an SDMS report of analytes that were found, detailed by batch number and name of compound. Within this hit list, users can click a link and SDMS outputs the printed TargetLynx report that is stored within SDMS. Analysts can review the report like they always have, but now they only have to concentrate on verifying the true positive hits (approximately 187 per year) instead of reviewing all 7,500 reports. BUSINESS BENEFIT The Waters solution is providing a number of benefits to the Karolinska University Hospital s Doping Control laboratory operations including: Increased revenue potential Greater sample throughput with UPLC/MS/MS. Greater productivity Approximately two hours are saved per batch in reviewing results for illegal compounds with SDMS and TargetLynx reports. Reducing risk of data loss SDMS automatically manages raw data backups from all LC/MS instruments. Better data accessibility All reports and raw data are fully text searchable from within SDMS, reducing the time needed to locate critical information. Connecting science to the business of the hospital TargetLynx and SDMS have automated and streamlined results calculations, review, and consolidated reporting. Waters, ACQUITY UPLC, NuGenesis, and UPLC are registered trademarks of Waters Corporation. Quattro Premier, MassLynx, TargetLynx, and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners. Waters NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

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55 Increasing the Throughput of Physiochemical Profiling with ProfileLynx Application Manager for MassLynx Software The client: Physical Chemistry Group at a Major Pharmaceutical Company BACKGROUND The Physical Chemistry group at a major pharmaceutical company was created to support discovery projects in hit identification, lead identification, and lead optimization phases with early physicochemical data gathering. The Discovery groups send test requests for selected compounds simultaneously to respective departments via the Chemical Support (CS) team within the Chemistry department. The Chemistry department is where all synthesized compounds are collected and stored. Compounds are sent out for testing according to the requests, as either standard stock solutions or solid samples. The Physical Chemistry group is made up of three analytical chemists running two LC/UV/MS systems. Each of these systems consist of a Waters Alliance HT System with a 2996 Photodiode Array (PDA) Detector, and a ZQ Mass Detector, running on MassLynx Software. Testing is done in a 96-well plate format. Among the analyses performed by the team are identification, purity, stability, and solubility tests. ID and purity evaluations are always included in all solubility and stability tests and demand additional processing of data. By implementing ProfileLynx into their existing LC/MS workflow, the chemists reduced the amount of time it takes to perform these tests from 51 to just 20 hours. CHALLENGE A screen solubility test of 48 samples took approximately 51 hours of analyst time, from the time that the samples were received to when the data was entered into the database. For a plate containing 48 duplicate samples, the variety of tasks involved: 4 hours doing sample prep and running the samples 18 hours in the office collecting compound and plate information codes, predicted properties, structures, and creating appropriate sample lists 8 hours evaluating purity 19 hours doing the solubility calculations n 2 hours inputting the final data into the company s database The analyst would get results over a week later. The Physical Chemistry group recognized that testing results were taking too long. They needed to significantly reduce bottlenecks in data management and analysis, as well as instrument resources, to improve their ability to support discovery projects especially since incoming work volume was increasing. 55

56 THE SOLUTION Creating the proper tools for collecting sample information from the database, formatting sample lists, and analyzing the data generated consumed a great deal of analyst time. By implementing ProfileLynx a specialized Application Manager for MassLynx Software that automates processing of physicochemical property analyses into their existing LC/MS workflow, chemists reduced the amount of time it took to perform these tests from 51 to just 20 hours (Figure 1). Office time was reduced from 17 to 2.5 hours. Because of the improved reporting capabilities of ProfileLynx, the solubility evaluation now takes just 4 hours instead of Manual Process 2005 ProfileLynx Time (hours) Lab time Office time Evaluation ID/Purity Evaluation Solubility Database Figure 1. Chemists time distribution for a screen solubility test of 48 compounds using a manual process (top) versus ProfileLynx implementation (bottom). BUSINESS BENEFIT While the LC/MS sample analyses were efficient for the screen solubility test, processing data and interpreting the results required tedious and time-consuming data manipulation and calculation. By introducing ProfileLynx and other tools such as MassLynx templates into their workflow, the customer has saved about 30 hours on the solubility screen for each set of 48 compounds. The time is now used in the implementation of other tests. As a result of the overall time savings, the group is able to analyze more samples, as well as provide the critical information necessary to make decisions about possible lead candidates more quickly. Because of the success of ProfileLynx with this evaluation, the software will be implemented with other tests within the Physical Chemistry group, including solid solubility, stability, and ELogD. WATERS SOLUTIONS FOR LEAD OPTIMIZATION Waters system solutions for lead optimization provide an automated, efficient selection process for determining compounds that have potential to become successful therapeutics. These solutions combine the strengths of Waters instruments, chemistries, software, and customer support to assist discovery labs in characterizing compounds faster, easier, and more cost effectively. Waters MassLynx Software and its ProfileLynx Application Manager streamline data management for physicochemical property profiling. MassLynx interfaces with upstream data systems to build sample lists used for data acquisition, while ProfileLynx automates the processing of chromatography-based data for physicochemical property analysis. Waters and Alliance are registered trademarks of Waters Corporation. MassLynx, ProfileLynx, ZQ, and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

57 High-Throughput Food Safety Lab Automates QA Data Interpretation and Recordkeeping with NuGenesis Sdms And MassLynx Software Client: Agri-Food and Biosciences Institute background The Chemical Surveillance Department (Veterinary Sciences Division) of the Agri-Food and Biosciences Institute (AFBI), a UK-based organization, tests food of animal origin for residues of both banned substances and licensed veterinary drugs. The department is staffed by approximately 60 scientists, who analyze approximately 35,000 samples annually, utilizing a variety of analytical technologies including LC/MS/MS. Laboratory procedures are regularly audited by regulatory agencies and accreditation bodies to ensure that the analytical methods are appropriately validated, demonstrating fitness for purpose, and to ensure that the lab is carrying out its duties in accordance with accepted standards set by the European Union (EU). This includes maintaining accurate records, continuity of evidence, and effective audit trails on all samples that enter the laboratory, including date received, date tested, test method, and date released. Failure to employ acceptable, well-defined and documented methods or inadequate recordkeeping could result in loss of accreditation certification. CHALLENGE EU legislation demands that tandem mass spectrometric confirmatory methods monitor a minimum of two daughter transition ions when confirming the presence of veterinary drug residues in food of animal origin. Recent advances in instrumentation have provided the ability to monitor ever-larger numbers of transition products in much shorter periods of time. One such technique employed by AFBI is the Waters ACQUITY UPLC System with the Quattro Premier XE tandem quadrupole Mass Spectrometer. The ACQUITY UPLC System combines unique instrumentation and column chemistries to yield dramatically improved resolution and speed. Combined with the Quattro Premier XE s fast data acquisition rates and ability to rapidly switch polarity monitoring positively and negatively charged compounds in a duty cycle of about 20 milliseconds the system can generate more data in a shorter time scale. Through Waters integrated Informatics solutions, AFBI has successfully addressed regulatory and technological challenges and significantly improved workflow and data management. Laboratories involved in drug residue testing are continually working towards extending the scope of multi-residue analytical techniques in an effort to reduce turnaround times and improve cost effectiveness. With EU regulations necessitating the acquisition, processing, and careful documentation of vast quantities of data and resultant sample information, the food testing laboratory is faced with a formidable information management challenge. 57

58 THE SOLUTION To analyze and manage the large quantities of data produced by the Waters analytical system for food safety, AFBI selected an integrated Informatics solution consisting of Waters MassLynx Software for system control and data acquisition, paired with its TargetLynx Application Manager, and the Waters NuGenesis Scientific Data Management System (SDMS). TargetLynx automates data acquisition, processing, and reporting for quantitative MS results and it incorporates a range of confirmatory checks that identify samples that fall outside of user-specified or regulatory thresholds. Given the sheer volume of data generated, however, TargetLynx reports can become very large, creating problems associated with archival. With NuGenesis SDMS, both electronic reports and raw data are captured from any instrument in the laboratory and are automatically stored and indexed within a searchable database. Data can be easily retrieved and shared among scientists throughout the organization. BUSINESS BENEFIT The Waters solution is providing a number of benefits to AFBI s laboratory operations including: Ensuring regulatory compliance through automated TargetLynx calculations demonstrate that the relevant EU legislative criteria are being fully met. Quantifying a single analytical batch often requires thousands of calculations and comparisons, which can all be fully automated using TargetLynx. Storing, indexing, and retrieving electronic data from a variety of analytical instruments produced by multiple vendors. What would previously have been thousands of pages of hard copy reports have become fully searchable electronic documents. Easily integrating scientific instruments with office software and a LIMS database. Providing instant access to original experimental raw data to any scientist connected to SDMS, allowing conversion of data to critical information. Improving productivity through automation of QA data interpretation and recordkeeping. This removes the need for manual transcription of quality assurance data, since data can be automatically extracted from captured reports. Automating the time-scheduled backup of critical instrumental data files generated by any vendor s instrument, or any electronic file on any PC. n Eliminating the need for generation and archival of thousands of pages of hard copy reports, and the costs associated with their production. The ACQUITY UPLC System, combined with the Quattro Premier XE Mass Spectrometer has improved sample throughput and is generating better quality data at a faster rate than ever before. With Waters integrated Informatics solutions, AFBI has successfully addressed regulatory and technological challenges, and significantly improved workflow and data management of key information within its analytical food testing laboratory. Waters, ACQUITY UPLC, and NuGenesis are registered trademarks of Waters Corporation. Quattro Premier, TargetLynx, MassLynx, and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

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61 Analysis Order Turnaround Times Reduced by 25% with Analytical Workflow Manager Client: A Global Pharmaceutical Company BACKGROUND A global pharmaceutical company develops drugs to treat a variety of disease conditions including cancer, heart disease, and HIV. The company s scientists rely on as many as 30 analytical testing labs that continually analyze thousands of chemical compounds used in or generated by the drug development process. Structural chemical analysis assists researchers in the discovery of promising new products for medical and industrial applications, while impurity profiling helps assure the quality of its products. The research analytical laboratories operate as service centers that accept samples for analysis from researchers and quality assurance technicians, routing the samples through tests in one or more labs. The samples are then returned along with the analysis reports to the requesters. This entire analysis process was paper based. CHALLENGE A flexible solution was required to minimize the manual paper-based processes between the research chemists and the analytical laboratories. This required eliminating the paper-bound chemical analysis processes at the customer s site and developing an efficient online workflow and system for sharing data. We wanted to enable the labs to combine their results into a data warehouse so we could provide value-added research services. And we wanted the researchers to be able to readily benefit from the analysis data that their colleagues had requested, which would lead to greater collaboration and fewer duplicate analyses, said the manager of the nuclear magnetic resonance laboratory. THE SOLUTION Waters Analytical Workflow Manager (AWM) and a site-wide deployment of the InSpector Analytical Data Viewer were installed to support researchers at the pharmaceutical company s major site. Analytical Workflow Manager, an analytical laboratory collaborative workflow management system with its integrated InSpector Software, met all of the customer s technical requirements. AWM was rolled out compliant-ready, helping the client meet the demands of 21 CFR Part 11 and applicable predicate rules where they apply to the documentation of lab workflow and data procedures through valid digital records and signatures. This solution from IBM and Waters Laboratory Informatics lays the foundation for a new era of discovery based on researcher empowerment and global collaboration. LAB MANAGER, GLOBAL PHARMACEUTICAL COMPANY The initial rollout served three customer labs. Analytical Workflow Manager is currently used by more than 400 researchers and 40 lab technicians. In this deployment, AWM was scaled to process up to 20,000 analysis orders per year and store 50,000 result sets. 61

62 As the focal point for all analysis performed within its three participating labs, AWM integrates with several existing systems. To minimize user training and promote user acceptance, an interface was developed between the newly deployed systems and the customer s virtual electronic laboratory notebook workbench software. The interface allows researchers to place orders for analysis and access the results. The AWM receives order requests from the electronic laboratory notebook workbench software system, triggering the delivery of requests to the lab technicians. Waters also integrated AWM with testing equipment in the labs and with the customer s classical LIMS environment. The LIMS receives notification of incoming orders, tracks the tests performed, and routes information to the customer s SAP system to efficiently generate billing for each order. AWM can run on a broad range of servers, from a small Intelbased system to clustered Linux, UNIX or mainframe platforms. This scalability and flexibility made the AWM s WebSphere implementation technically and economically efficient; backed by IBM support, it was also a low-risk option. The deployment included IBM Systems with WebSphere Application Server (Advanced Edition), WebSphere Studio Application Developer (formerly IBM VisualAge for Java), and Servers (IBM RS/6000 SP). BUSINESS BENEFIT Turnaround time for analysis orders was reduced by 25% in the first year after rollout. The system promotes information sharing and collaboration among researchers across the company. By integrating analysis reporting with workflow and billing processes, Analytical Workflow Manager helps the customer improve laboratory productivity while reducing errors. This breakthrough is immense. With the expertise of both IBM and Waters Laboratory Informatics, we have transformed a dead resource into a front-line research and workflow tool, while opening up our analytical lab to the rest of the organization, said the lab manager. The customer plans to implement AWM in five more analytical labs, and extend the system to research and development departments in other organizations within the company. The customer believes that their strong relationship with Waters and the support from IBM are providing strong impetus to proceed. This solution from IBM and Waters Laboratory Informatics lays the foundation for a new era of discovery based on researcher empowerment and global collaboration, the manager said. While AWM improves day-to-day productivity in the labs, it also builds a database of analysis results, running on an IBM RS/6000 SP server. The database, which the customer estimates is growing by three gigabytes every month, will serve as the basis for collaboration among researchers. Waters is a registered trademark of Waters Corporation. The Science of What s Possible is a trademark of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Printed in the U.S.A. September EN LB-AP Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F:

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64 Waters, ACQUITY UPLC, UPC, 2 UPLC, Symmetry, Atlantis, XTerra, Empower, Alliance, ACQUITY, and NuGenesis are registered trademarks of Waters Corporation. Q-DIS/QM, MassLynx, Quattro Premier, TargetLynx, ProfileLynx, ZQ, OpenLynx, XBridge, and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners. NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd s Register Quality Assurance. NuGenesis ELN and Analytical Workflow Manager are covered under a formal Quality Management System certified by the TÜV Rheinland Group Waters Corporation. Produced in the U.S.A. May EN LB-PDF Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F: