MasterControl. Summary of MasterControl Software Solutions APPLICATIONS ADD-ONS BUSINESS PROCESSES

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1 MasterControl Summary of MasterControl Software Solutions APPLICATIONS ADD-ONS BUSINESS PROCESSES Toll Free: Fax: INDUSTRY SPECIFIC INTEGRATIONS & CONNECTORS

2 Copyright MasterControl, 2010 All rights reserved Revision 3 This document summarizes the many software solutions developed by MasterControl Inc. to help pharmaceutical, medical device and other companies meet document control, training, and other quality standards and regulatory requirements. COMPLIANCE ACCELERATED

3 Contents Summary of MasterControl Software Solutions Summary of MasterControl Software Solutions Introduction...4 MasterControl Solutions TotalPharma...5 Pharma R&D...5 MasterControl MD...5 MasterControl ENG...6 QMS CAPA...6 GCPDocs Express...6 DHF Express...6 MasterControl TotalMFG... 7 Submissions Ready Docs... 7 MasterControl Core Modules Analytics...7 Documents...7 Process...8 Supplier...8 Training...8 QAAD...8 MasterControl Add-Ons Classes...8 Copies...8 Enterprise...8 Exams...9 Forms QuickView...9 Global Licensing Server... 9 Projects...9 Rules...9 Transfer OQ...9 MasterControl Business Processes Audit...9 Business Process Library Change Control...10 Customer Complaints...10 Deviations...10 Electronic Batch Records (EBR) Equipment Calibration...10 Equipment Maintenance HR Finance...10 Nonconformance Out-of-Specification (OOS) Risk Analysis Supplier Deviation MasterControl Industry-Specific Products Bill of Materials (BOM) DHF JumpStart emdr GCPDocs JumpStart...12 PDM Connectors...12 Submissions Gateway...12 Submissions Locker...12 MasterControl Integrations and Connectors API Toolkit...12 Document Connections...12 Kofax Connector...12 MS Word Integration...13 Outlook Integration PDMWorks Connector...13 Pro/Intralink Connector...13 QAAD API Suite...13 SharePoint Connector...13 WindChill Connector...13 MasterControl Services Data Migration Services...14 Educational Services...14 Salt Lake City Education Center QMS CAPA Workshop...14 QMS Root Cause Investigations Workshop Consulting & Implementation Services Implementation Best Practices Integration Services...15 Project Management Services Technical Support Services Customer Website...16 Validation Services and Solutions Validation Best Practices Service Validation Training...17 Custom Protocol Design Services Customer Protocol Execution Services GxP Documentation Services Configuration Services...18 Summary of MasterControl Software Solutions

4 Introduction Originally established in 1993, MasterControl Inc. has a solid track record of providing Web-based, end-to-end solutions for the pharmaceutical and biotech industries, medical device companies, and other organizations that must meet strict quality and/or regulatory standards. Our solutions are designed to assure compliance while helping companies get their products to market faster. MasterControl is a steadily growing company that has increased its customer base by close to 50% since Financially, we are a very strong company. During the fiscal year of 2008, for example, we increased our revenue by 44%. Currently, we have over 400 satisfied customers worldwide, with offices in North America, Europe and Asia. We are continuously developing new software and refining existing software to meet customer needs. We actively seek customer feedback and suggestions. The responses we receive in combination with our exceptional industry experts and product developers are what enable us to offer solutions that truly are end-to-end. Our software is designed to meet the needs of different sized organizations, and to easily accommodate expansion as companies grow. Our solutions incorporate completed validation and support documentation of IQ/OQ tests performed at MasterControl (in the form of transfer operational qualification or TOQ). This greatly reduces validation requirements, validation time, and the overall cost of validation. We hope that the following pages will be helpful to you. If you have any questions, please don t hesitate to contact us at (U.S.); +44 (0) (Europe); or (Asia). You may also be interested in visiting our Web site, Page 4

5 MasterControl Solutions TotalPharma This solution is specifically designed to help pharmaceutical and biotech companies manage all their documents and automate all their regulatory-related processes as well as employee training via a single, Web-based platform. The software facilitates document creation using companyapproved, best practice templates for every type of document a company uses, including clinical trial documents. Comprehensive project planning and management software automates task assignment, routing, escalation, and tracking, while speeding up a company s processes, avoiding potential bottlenecks, and increasing management oversight. Collaboration workspaces can accommodate multiple departments and corporate sites, outside suppliers, consultants, etc. To facilitate continuous supplier monitoring and assessment, the TotalPharma solution provides a simple dashboard-like interface for all supplier-related quality information. import functionality allows users to link related documentation to critical correspondence with regulatory authorities, CROs, or suppliers, so that everything can be tracked together. In addition, the solution offers MS Word 2007 integration, automatic creation of PDF renditions with appropriate bookmarks and e-signature manifests. Optional connectors to submissions publishing tools, scanning tools, and other commonly used enterprise applications such as SharePoint provide additional benefits. Pharma R&D This Web-based solution dramatically decreases the time spent locating/managing critical documents during the R&D phase of a pharmaceutical or biotech company. Other benefits include preconfigured templates and routes for ensuring that documents are created, reviewed, and approved correctly the first time; state-of-the-art benefits also include cross-functional team collaboration, project management software, and automated training on approved changes to documents. The solution also incorporates MS Word 2007 integration, automatic creation of PDF renditions with appropriate bookmarks and e-signature manifests, and an out-of-the-box, best practices configuration for clinical trial documentation which minimizes configuration time and makes it possible to move to production faster. MasterControl MD This end-to-end software solution for medical device manufacturers enables companies to get their products to market faster while simultaneously assuring regulatory compliance. By providing a Webbased workspace for collaboration between all departments (engineering, manufacturing, marketing, quality, and regulatory) early in the development cycle, the solution shortens development time and improves product success. Via workflows and electronic signature approvals, the end-to-end solution automates document management and quality events such as CAPA and customer complaints, as well as medical device reports (MDRs) and nonconformance reports (NCMRs). In addition, the solution automates audits, employee training, project management, and supplier management. MasterControl MD integrates seamlessly with CAD, Outlook, MS Word, MS Project, and other tools medical device companies use on a daily basis. Page 5

6 MasterControl ENG This solution efficiently manages the continual changes to engineering designs and product specs. It also gets manufacturing, marketing, quality, and regulatory personnel involved early in the development cycle to maximize the likelihood of product success. The Web-based document management software allows design engineers to collaborate in their native CAD environments and manages updates to the DHF. MasterControl ENG also provides validation software, in addition to software for project management, BOM and supplier management. QMS CAPA Because CAPA is such an extremely critical part of a quality management system (QMS), MasterControl offers three CAPA solutions to meet the varying needs of different companies. QMS Ready Set is designed to be used out-of-the-box by small, growing companies. QMS Custom Fit is for midsize to large companies that need more robust functionality to manage multiple input sources and provide additional controls. This highly tailorable solution provides unique Intelligent Forms that act as a virtual consultant to guide users through important processes such as risk assessment and investigation. QMS Total Advantage is the most robust CAPA system available. It includes all of the features of QMS Custom Fit, in addition to the ability to tie together all aspects of a company s QMS system (document control, CAPA, training, design control, etc.). This ensures, for example, that changes to product designs, SOPs, etc., initiate new training for appropriate personnel. Inputs to MasterControl QMS CAPA can come from any one of three sources: an event management system (where problematic events are analyzed and, if possible, resolved to reduce the number of events funneled into CAPA); specific entry points such as complaints, deviations, OOS, etc.; or a CAPA management system which collects problematic events before sending them to the company s CAPA system. All three solutions are Web-based, so that they can connect (from virtually anywhere) employees, vendors, customers, and anyone else who needs to be involved in CAPA. In addition, all three solutions provide tracking, notification, escalation, time-stamped audit trails, reporting, and electronic signature capabilities. GCPDocs Express This software solution is specifically designed for early stage pharmaceutical and biotechnology companies. The preconfigured, hosted system facilitates collecting, organizing and reviewing the clinical, nonclinical and regulatory documents required to meet good clinical practice requirements, without the expense of hardware and dedicated system administrators. DHF Express MasterControl DHF Express is an integrated solution designed to speed up the launch of new products for small medical device companies. The software connects users, data and processes in a centralized system, and automates collaboration, routing, follow-up, escalation, and the approval of important design control and other documentation. Page 6

7 MasterControl TotalMFG This end-to-end solution automates document management and quality events such as nonconformance reports (NCMRs), CAPA, customer complaints, audits and employee training. The Web-based solution includes collaboration workspaces (where, for example, product developers, manufacturing and suppliers can collaborate from virtually anywhere using the tools they are most comfortable with). Additional benefits include automated approval workflows and project management tools (which speed up manufacturing by reducing bottlenecks and inefficiencies). The system streamlines supply chain management to help prevent receiving delays, product rework, and scrapping of product. It also provides an overview of the development pipeline to ensure that purchasing decisions are based on accurate data. MasterControl TotalMFG integrates seamlessly with CAD, Outlook, MS Word, MS Project, and other tools medical device companies use on a daily basis. Submissions Ready Docs This solution is designed for companies that want to implement a complete document management/ document control solution in preparation for a regulatory submission. The software provides submission-related document templates, as well as preconfigured document types specific to a company s submission. Collaboration functionality and MS Word integration enable cross functional teams to collaborate on submissions documents, while ensuring their reliability and security. The Submissions Gateway software (see page 12) provides a simple mechanism for creating copies of approved submission documents in the desired folder structure to share with a submission publishing group or contractor. MasterControl Core Modules Analytics MasterControl Analytics is an easy-to-use software application that enables non-technical users to develop sophisticated, customized reports. Once the report template is created, the user s work is done. Because the Analytics application is connected with the rest of the MasterControl system, data from other areas (for example, CAPA, Audit, Employee Training, etc.) are automatically retrieved, analyzed and reported on in real time. Documents MasterControl Documents assigns a unique identifier to each document, and automates the routing, delivery, escalation, and approval of documents. The software solution can handle all types of documents regardless of the software used to create them. MasterControl features a centralized, secure repository that makes search and retrieval easy during inspections and audits. The software solution s Web-based platform provides access to authorized users from any physical location. In addition, MasterControl Documents provides a virtual workspace for collaboration. The software allows one authorized user at a time to revise a document to avoid the confusion of multiple document revisions. Because the software is Web-based, team members can review, comment on, revise, or approve a document without having to be physically present with the rest of the team. Page 7

8 Process MasterControl Process expedites forms-based processes, and controls the user s ability to launch processes (based on his or her rights). This expedites processes and saves time and money, while reducing the potential for making mistakes. Configurable workflows automate routing to appropriate participants and can escalate tasks if timelines are not met. Tasks can be processed concurrently by multiple users or even groups. These features greatly speed up turnaround time. Supplier With MasterControl Supplier, all supplier status and quality information (such as non-conforming material reports) is contained in a single, easy-to-access location. In addition to providing an easily maintainable AVL, the Web-based solution features a user-friendly interface for accessing all documentation and records related to each supplier. Training Documenting training is critical for any regulated company. MasterControl automates the routing, tracking, documentation, training and retraining of training tasks. Whenever there s a change in an SOP or other document linked to a course, all affected employees automatically receive new training tasks and notification via their . Users are provided with training materials within the training tasks and their competency in relation to those materials can be documented through use of the Exam add-on. Configurable training reports show pending, past due and completed training, plus other critical information. QAAD MasterControl QAAD provides comprehensive, user-configurable and validated, off-the-shelf software for scheduling, managing, and reporting on audits, as well as responses to audit findings, CAPAs, and other QA activities. QAAD is used by more than 50% of the top 20 pharmaceutical companies, and is designed to be used by quality groups in any industry. MasterControl Add-Ons Classes With this add-on to the Training module, employees can view and sign up for a class associated with their training task. Employees can view when, where, and how many seats are available for each class. Completion of a class is documented in the course and can be viewed through the training file and Analytics reports. Classes, in conjunction with Exams, will ensure you have proper documentation of your employees training. Copies MasterControl Copies enables users with the appropriate rights to print controlled copies of documents. The copies are uniquely numbered, watermarked and tracked to ensure that only the most current version of a document is in circulation. The print date, document owner and location are recorded in the system to provide additional security. Enterprise This solution enables an enterprise-wide system to connect its various business units, while allowing individual offices to control their own processes. To reduce the potential for making mistakes, filters configured by each business unit limit access to information. Page 8

9 Exams With this add-on to the Training module, your company can document your employees competency in the course materials through an exam. Exam questions types include true/false, multiple choice, matching and others. They can be randomized so that employees receive different questions. After an employee takes an online exam, his or her exam is auto-graded and instantaneously recorded. Forms QuickView Forms QuickView enables managers to quickly review and approve the voluminous processes for which they are responsible on a daily basis. With the click of an icon, form data is displayed via the browser. Forms QuickView offers a browser user interface as an alternative viewer to Adobe Reader for MasterControl processes. Global Licensing Server The MasterControl Global Licensing Server add-on allows companies to share licenses with loosely coupled sister companies. When company A is at a peak time, company B may be using fewer licenses or may not be using them at all (if separated by multiple time zones). Projects With MasterControl Projects, the project plan is connected to the project tasks. When a document is approved or a process is completed, MasterControl automatically updates the project plan thereby eliminating the need for manual intervention. Rules MasterControl Rules enables managers to set thresholds for being notified of quality events such as customer complaints, raw material nonconformances, etc. This enables managers to receive alerts and respond immediately to (for example) a customer complaint received from 10 individuals, rather than having to wait for weekly or monthly customer complaint reports. Transfer OQ MasterControl Transfer OQ (in the form of transfer operational qualification or TOQ) provides completed validation and supporting documentation of IQ/OQ tests performed at MasterControl. This documentation serves as evidence that the functions of a MasterControl application perform correctly against specifications. MasterControl TOQ saves companies time and money by reducing the overall validation burden, and is a key component of MasterControl s continuous validation approach. As part of this solution, a MasterControl validation expert will perform a comprehensive validation risk assessment. MasterControl Business Processes Audit This solution connects the audit process with the rest of the quality system for a holistic approach to quality management. For example, it enables an investigation form for a potential CAPA to be launched directly from an audit finding form, thereby greatly streamlining the process and ensuring that audit-related activities aren t overlooked. Page 9

10 Business Process Library During a 12-month subscription period, this solution provides access to all of the solutions that comprise MasterControl s integrated quality suite. Users can start with one solution and add others as requirements demand without spending additional funds on software. Change Control This solution automates the change control process for faster turnaround. It offers a best-practice form that incorporates priority level, as well as escalations. Real-time reports provide authorized users with the status of all change control tasks. If MasterControl Training has been purchased, any change to a document/process that warrants new training will automatically send training tasks to the s of affected employees. Customer Complaints MasterControl Customer Complaints provides a secure, centralized platform for receiving customer complaints and storing all documentation pertaining to a complaint s investigation and correction. Deviations Deviations may occur at any point: during sampling and testing, raw material and finished product acceptance, manufacturing, and product distribution. MasterControl Deviations automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. Electronic Batch Records (EBR) The MasterControl EBR solution automates the routing, follow-up, and escalation of batch records for more efficient process management. Pre-configured forms simplify data collection and help minimize errors. An electronic inbox tracks all active tasks and provides the tools necessary for users to stay up-to-date. The solution uses the FDA-compliant framework (or S88 standard) as the basis for modeling a wide range of manufacturing processes. Equipment Calibration MasterControl manages the calibration schedule and automatically generates calibration tasks before due dates are reached. Detailed reporting capabilities provide insight into calibration activities and help avert bottlenecks. Equipment Maintenance MasterControl manages the equipment maintenance schedule and automatically generates preventive maintenance tasks before due dates are reached. Detailed reporting capabilities provide insight into maintenance activities and help avert bottlenecks. HR Finance MasterControl HR Finance routes preconfigured, electronic HR forms for electronic signature approval, and automates the delivery of notifications and follow-ups. A full set of configurable standard reports is provided; all reports can be further customized using MasterControl Analytics. Page 10

11 Nonconformance MasterControl automates data collection, routing, follow-up, and escalation of nonconformance events. The electronic in box tracks all active tasks and provides tools for staying on top of things. This enables approvers to review and sign off on nonconformances electronically. Out-of-Specification (OOS) The Out-of-Specification (OOS) software solution from MasterControl automates OOS processes (including routing, notification, escalation, and approval) to help companies comply with FDA CGMPs and 21 CFR Part 211 regulatory requirements. Because the software is Web-based, employees, customers, and suppliers can participate in the forms-based OOS process from virtually anywhere. Risk Analysis Many of MasterControl s quality solutions include triggers for performing risk analysis. The Risk Analysis software enables a team of risk experts (designated by your company) to automatically receive information (about a deviation, for example) that triggers a risk analysis. MasterControl supplies the risk metrics, which can be further defined by your company to match specific needs. This ensures consistent, objective and defensible quality decisions. Supplier Deviation MasterControl Supplier Deviation allows a supplier to request an exception to specification before the material is shipped. This avoids the receipt of shipments that are unacceptable to the quality department and saves a great deal of time and effort on the part of everyone involved. MasterControl Industry-Specific Products Bill of Materials (BOM) MasterControl BOM controls all BOM iterations generated during the design process and enables users to exchange BOM data with suppliers. Documents defining components are easily viewed from the BOM, ensuring that the right documents and revisions are used during the manufacturing process. MasterControl extracts BOM data from PDM systems and pushes it through to ERP systems automatically. DHF JumpStart DHF JumpStart is an out-of-the-box software solution requiring minimal systems administrator or user training. The software can be installed in a matter of days, to automate the collaboration, routing, follow-up, escalation, and approval of important design control documentation. Using electronic signatures further accelerates the approval process. LDAP integration is available. emdr The FDA s medical device reporting (MDR) regulation 21 CFR Part 803 requires device manufacturers to report to the FDA any deaths or serious injuries, as well as certain malfunctions associated with their devices. MasterControl emdr enables MasterControl users to implement their FDA adverse event reporting process electronically. Page 11

12 GCPDocs JumpStart This very affordable solution is specifically designed for growing pharmaceutical and biotechnology companies. It is preconfigured according to regulatory standards and industry best practices to give companies a jumpstart on organizing documents that will go into their NDA. The solution can later be customized and easily expanded to meet specific needs. PDM Connectors The MasterControl PDM Connectors application provides a straightforward means of applying document control to CAD data without forcing designers into a non-native application for managing their CAD files. CAD files are maintained by the native PDM solution while MasterControl creates PDF copies for official document control purposes such as routing, approval and production. Submissions Gateway This solution enables the regulatory submission documents contained within a company s centralized MasterControl document repository to integrate with the company s regulatory submissions tool. Submissions Locker With this tool, documents are approved in MasterControl and automatically copied to the Submissions Locker. The Submissions Locker provides a secure, Web-based location where access to submission documents can be easily controlled. After authentication, MasterControl allows your publishing tool of choice to access the Submissions Locker as a standard file share. All access rights are controlled exclusively by MasterControl login parameters. MasterControl Integrations and Connectors API Toolkit The MasterControl API Toolkit helps companies leverage their existing systems and keep costs down by allowing them to integrate MasterControl quality applications with their enterprise resource planning (ERP), customer resource management (CRM), manufacturing execution systems (MES), and product data management (PDM) applications. Document Connections Through MasterControl Document Connections, companies can complement their existing electronic repositories with MasterControl s powerful, process-specific applications for managing training, CAPA, audit, change control, customer complaints, nonconformance, and other quality processes. Kofax Connector Together, MasterControl software and Kofax s Ascent Capture allow users to directly upload scanned documentation into the MasterControl document control and management system. MasterControl permits users to scan and upload any portion of a document. Scanned images can be converted into searchable text. Page 12

13 MS Word Integration With the MasterControl MS Word Integration, users can control and manage MasterControl documents in MS Word For example, from MS Word 2007, they can search MasterControl s archives, create new InfoCards, attach documents as an InfoCard s main file, place main files in a collaboration, or simply save InfoCards for future use. Outlook Integration This solution allows users to complete most tasks entirely from their , facilitating approvals, process data entry, and similar tasks. More complex tasks have links in MS Word directly to the task in MasterControl, making them easy to complete and simplifying navigation through the system to find the tasks. PDMWorks Connector MasterControl s PDMWorks Connector provides users with a straightforward means of applying document control to CAD data without forcing designers into a non-native application for managing their CAD files. CAD files are maintained by the native PDM solution while MasterControl creates PDF copies for official document control purposes such as routing, approval and production. Pro/Intralink Connector The MasterControl PDM Connector for Pro/Intralink provides users with a straightforward means of applying document control to CAD data without forcing designers into a non-native application for managing their CAD files. CAD files are maintained by the native PDM solution, while MasterControl creates PDF copies for official document control purposes such as routing, approval, and production. QAAD API Suite The MasterControl QAAD API Suite enables authorized users to access the QAAD database programmatically through a validated interface. This eliminates the need to enter client database records individually via the application s user interface. The QAAD API Suite consists currently of 70 API commands, which can be called from any application that supports Web services. SharePoint Connector With MasterControl, users are guaranteed that they are working with the most current version of a SharePoint Connector document. Stored in MasterControl s secure, centralized repository, the most recent versions of documents are easily accessed with a mere click of a mouse. Links to these documents are easily added to the SharePoint library, making access simple for the SharePoint user. WindChill Connector The PDM Connector for Windchill software provides users with a straightforward means of applying document control to CAD data without forcing designers into a non-native application for managing their CAD files. CAD files are maintained by the native PDM solution while MasterControl creates PDF copies for official document control purposes such as routing, approval, and production. Page 13

14 MasterControl Services Data Migration Services For companies using MasterControl s client/server system who now want to upgrade to the MasterControl web-based platform, the Professional Services team coordinates the entire migration effort. This helps maximize the benefits of new technology while minimizing disruptions to your dayto-day operations. When employing MasterControl s Data Migration Services, all migrations are implemented using our proven project methodology. This methodology utilizes a full test migration at our facility prior to the live data migration at your site. This ensures that any data integrity issues are identified and corrected prior to the final migration of your critical data. Following a successful test at our facility, the consultant assigned to your project will repeat this comprehensive migration test plan when onsite. Educational Services MasterControl Inc. provides a variety of educational resources to help you gain a complete understanding of the MasterControl software suite, with the ultimate goal of improving your organization s productivity and efficiency. Whether your needs focus on enabling a new system or building a stronger understanding of a current system, MasterControl is ready to help you meet your goals. Our Education Services Department offers a variety of instructional materials and courses designed to teach both users and administrators how to get the most from MasterControl s products. Salt Lake City Education Center Hands-on training in a classroom environment is offered at MasterControl s Education Center, located at the company s headquarters in Salt Lake City, Utah. The Education Center is a working classroom designed to help administrators, engineers, quality professionals, and others in your organization become proficient with the array of MasterControl products. Our state-of-the-art facilities provide each student with a workstation loaded with the most current applications, allowing them to explore every component of MasterControl. Courses are taught by subject matter experts from our various departments and professional services consultants that make their living in the field. Students that raise questions in class often find themselves being handed a flash drive with a solution that was just implemented at a customer s site by one of our instructors. The Education Center can also provide training at a site of the customer s choosing. In addition, recorded online training is available 24/7. QMS CAPA Workshop The Life Science industry needs to have trained personnel that can be counted on to identify and investigate root causes and effectively implement solutions for corrective and preventive actions. MasterControl has custom fit the PathWise CAPA course for those companies that are integrating electronic systems and applying CAPA skills into those forms. It is designed to effectively develop these individuals and provide them with the skills and tools to become superb investigators and problem solvers. The course overview consists of Issue Review, Root Cause Analysis and Implementation and Effectiveness Checking. Page 14

15 QMS Root Cause Investigations Workshop The role of the troubleshooter has traditionally stressed reacting to problems. Personnel charged with solving problems tend to take a shotgun approach when something goes wrong, do whatever it takes to correct it. As a result, many problems reoccur due to focusing on symptoms instead of the root cause. Pains common to many organizations include product or equipment problems with unknown causes that result in delays, scrap, rework, and/or downtime; investigators lack expertise and are unable to solve problems and find causes; countless open CAPAs with no resolution; inadequate processes to utilize when root cause analysis data is brought forward, and an inability to easily communicate and transfer step-to-step investigation knowledge. The MasterControl QMS Root Cause Investigations workshop alleviates these pains by developing personnel into superb problem solvers. Consulting & Implementation Services Companies with outdated business processes can find themselves tied up in bureaucratic knots. MasterControl s experts analyze your business processes, suggest new ways to manage them, and lead the way to automated systems that put you back in control and most importantly save you time and money. Our experts meet with your staff typically employees in IT, quality, regulatory compliance, manufacturing and finance to review your business flows and design better ways to accomplish organizational goals. Implementation Best Practices The very definition of successful implementation is the achievement of desired results as soon as possible with the least amount of interruption to normal workflow. At MasterControl, the primary measurement of success is making sure that the customer s implementation process is smooth and trouble-free. During an implementation, MasterControl consultants are with you every step of the way, engaging your team in analyzing problems, devising solutions that make the most of MasterControl solutions, and configuring the system to provide maximum value for the customer s investment. Integration Services In addition to using MasterControl software to automate internal processes, companies frequently deploy a variety of other third-party software applications as well. Examples may include enterprise resource planning (ERP), customer resource management (CRM), clinical trial management system (CTMS), manufacturing execution systems (MES), and product data management (PDM) applications. You ll be happy to know that MasterControl integrates nicely with many major software applications typically used by our customers. In some cases there are many connection points between MasterControl s system functionality and the functionality of other applications. When properly configured, these connection points can vastly improve the overall performance and automation of your entire company. The MasterControl Connections Toolkit and QAAD API Toolkit enable companies to bridge that functionality by integrating MasterControl products with third party systems. Page 15

16 Project Management Services MasterControl offers Project Management Services to help alleviate the challenges of project management and ensure successful implementation of your new software. Through this service, MasterControl will provide the continuity and quality that you need throughout the deployment process. An experienced MasterControl project manager will provide management expertise, serve as a project champion, coordinate activities, and communicate critical milestones. This provides a single-point of accountability and communication for the entire project. Technical Support Services Even the most proficient users of MasterControl occasionally have questions about its specific features, functions or benefits. Technical support is the service provided by MasterControl to answer questions and provide solutions to customers using the software. MasterControl maintains several levels of support, ranging from online self-help via the customer website to one-on-one, in-person assistance. Our goal is to provide 100% customer satisfaction. The technical support program includes the Self-Service Web Portal ( Maintenance Support Service, IT Training, MasterControl Installation and Custom Support Options. MasterControl products are supported according to several time-based phases: Mainstream Support, Extended Support and Ongoing Support. Customer Website MasterControl s Customer Website provides a vast amount of information and tools to help you become more productive. On this Website you can find technical support documents, support, a customer forum, product and education information and more. This password-protected site is updated regularly to provide the latest support information to make using your MasterControl software an easier and more productive experience every day. The Customer Website can be accessed by pointing your browser to Validation Services and Solutions Our team of highly skilled experts has a wide range of industry backgrounds and collective experience performing software validation. Whether you re looking for a completely outsourced model, formal training, or just a little advice to assist your internal efforts, our team of seasoned professionals will help you meet today s regulatory requirements and complete your systems process compliance. Due to constraints in resources, deadlines, or internal priorities, many MasterControl customers request an outsourced model to help with their validation requirements. MasterControl stands ready to assist with this effort at all levels including project assessment and planning, project management, executing protocols, systems audits, conducting third-party reviews, and more. And since we communicate with you frequently throughout the entire validation process you can rest assured that problems are being addressed and that the entire project is moving forward as efficiently as possible. It has been our experience that each customer has unique needs and often requires a tailored approach to validation. Because of this, we take great care to understand the scope of each project before it begins. Contact your Customer Relationship Manager (CRM) to learn more and to request a customized proposal that focuses on your specific needs. Page 16

17 Validation Best Practices Service Some MasterControl customers prefer to execute our protocols and validate products independently. If this is your preference, MasterControl s Validation Best Practices consulting team will assist you with the organization of your validation project, filling in the gaps to ensure a smooth execution and successful implementation. Validation Training If you re new to validation, MasterControl s Validation Training Course may be just what you need to get up to speed. This two-day course guides you through the FDA and GAMP regulations and methodologies for validating automated systems, applications, or processes. The course familiarizes you with the proper methods for planning and executing a computer systems validation project and provides examples and exercises on the usage of the MasterControl validation toolkit and validation test protocols. Discussions during the course include information on common mistakes that can be made during execution that could cause overall project delays. Contact either your Customer Relationship Manager (CRM) or your Regional Sales Manager (RSM) to find out more about how MasterControl s Validation Training Course can help you experience a smoother, faster validation process. Custom Protocol Design Services Our consultants can assist you in the complete development of customized Performance Qualification protocols. Consultants begin the development process through the collection of the onsite configuration and usage procedures/work instructions for the MasterControl Quality Suite Application. The data collected will then be used to create a baseline protocol that covers Data Integrity, Security Integrity, and Electronic Approval Integrity testing from processes covering record creation, approval, and secure retrieval. Testing supports multiple sites and users performing simultaneous operations, proving both system stability and overall usage integrity. This service is normally contracted as a part of the PQ Execution process, providing a full Performance Qualification solution. Customer Protocol Execution Services If you don t want to go it alone, a consultant from the MasterControl Validation Services group can guide your test team through every feature and function of the MasterControl Quality Suite application. The protocols are based on industry standards and provide full traceability back to the feature definitions of the product s Functional Requirements Specifications. They contain all of the necessary guidelines for both full validation and re-qualification testing for systems upgrades. IQ Execution, OQ Execution and PQ Implementation services are available. GxP Documentation Services MasterControl offers three types of GxP documentation services: Pre-IQ/OQ Documentation Services: We develop the Validation project management documentation for you, defining the validation project activities, requirements and risks. The deliverables for this task include the Validation Plan, Risk Management Plan, and User requirements specification. Upon delivery, the validation professional will review the document contents with you. Page 17

18 Test Reporting Documentation Services: Our consultant will develop the Testing Summary reports and Final Validation report for the project. Included in this documentation delivery is a review of all of the testing and project milestone information for the creation of the IQ/OQ Test Summary Report, PQ Test Summary Report and Final Validation Project Report. Our validation professional will perform a basic general review of the document contents with the customer upon delivery. Usage SOP Documentation Services: This service tasking is the development of the general usage SOPs for the project. Included in this documentation delivery is the development of the Systems Administration / Configuration SOP as well as the User Account Management SOP. In addition the Validation professional will perform a basic general review of the document contents with the customer on delivery. Configuration Services MasterControl s Upgrade Configuration Services will assist current MasterControl customers by providing the necessary knowledge and skills to quickly update, configure, train and plan the required validation and project activities needed to implement the newly upgraded features of the MasterControl system MasterControl Inc. All rights reserved.0 Page 18

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20 Corporate Headquarters: MasterControl Inc S E. Ste. 110 Salt Lake City, UT United States Phone: Fax: European Headquarters: MasterControl Global Limited First Floor North Wing Matrix Building Basing View Basingstoke RG21 4FF United Kingdom Phone: +44 (0) Fax: +44 (0) Germany Office Mendelstrasse Muenster Germany Phone: +49 (0) Fax: +49 (0) Asian Headquarters: MasterControl KK Aios Akihabara Ueno Taito-ku Tokyo Japan Phone: +81 (3) Fax: +81 (3) Copyright 2010, MasterControl Inc.