Biorepository and Biobanking

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1 Biorepository and Biobanking

2 LabWare s solution for biorepositories and biobanks combines powerful specimen tracking and logistics capabilities with specimen processing and workflow management features. The result is streamlined management of the total lifecycle of each biospecimen: collection, pre-registration, receipt, processing, QC, storage management, request, retrieval, and distribution. LabWare s biorepository software can be deployed via the web on a variety of common browsers such as Internet Explorer, Google Chrome, Apple Safari or as a Windows client. The system is highly scalable, and can use popular databases such as Oracle and SQL Server. The solution is based on LabWare LIMS, which has been proven in over 1300 installations worldwide, with system deployments ranging from a few users in a single laboratory all the way through to implementations supporting thousands of users located in multiple sites around the world. Customer benefits include: Reduced turnaround time from biomaterial request to shipping. Improved sample tracking, query, and chain of custody. Elimination of lost samples and compromised sample integrity. Improved quality via integrated quality control tools. Improved efficiency and reduced costs via time savings for many tasks. Flexibility to quickly accommodate new business requirements. Authorized users can manage all information about specimens, donors, consent information, and studies with precise control over individual user s data access and functional privileges. LabWare s biorepository solution supports compliance with 21CFR part 11, CAP, and IRB requirements as well as ISBER best practices and guidelines. LabWare can easily interface with a wide variety of laboratory instrumentation, robotics, and automated storage systems. Interoperability tools enable seamless information exchange with other enterprise systems within the biorepository and also with external stakeholders via web services, HL7, ASTM, file transfer, and direct database communications. Powerful and flexible reporting and query tools are available which simplify the task of retrieving information to run statistics, management reports, or ad hoc queries. For ease of use and enhanced productivity, LabWare s configurable dashboard provides access to essential information, including such things as pending work, performance metrics, and key status indicators for processes within the biorepository operation. Dashboards can be tailored specifically for the user or the role to provide optimized views of the data and workflow alerts. LabWare 2

3 Provided below is an example of a dashboard screen with key performance metrics and navigation buttons to commonly used functions within the system which have been configured for a Biobank Manager. Configurable tabular display of biobank shipment information. Configurable display detailing info on selected shipment. Configurable dashboard menu options for quick access to key functions. Study Definition & Subject Management For biobanking applications that manage specimens that are associated with studies and/or projects, LabWare LIMS includes powerful features that enable the biorepository to ensure compliance with the requirements detailed in the protocol. Configurable templates are used to define the study or the project in such a way that the system can be used to drive the workflow activities, to validate the data that is collected, and to control what information to include on reports or in data extracts. The LabWare solution also includes fully integrated and configurable clinical protocol and subject management tools that track protocol contents, specimen requirements, and subject details such as consent and visit tracking. Additional capabilities include production and distribution of sampling kits and requisitions, order and fulfillment management for kits and supplies, and inventory tracking of specimen collection kits and kit components. Specimen Collection, Registration, Shipment, and Receipt at the Biorepository LabWare accommodates specimen registration either individually or by batch using spreadsheet style grid entry or electronically via file import. It should be noted that there is no limit to the number of fields than can be assigned to a specimen template, and no limit to the number of templates that can be created to cater for the different types of specimens that may be encountered. Numerous fields are provided out of LabWare 3

4 the box and customers can add (configure) new fields as and when required. LabWare tracks each shipment to enable chain of custody tracking of each item. Shipments can be received and registered into the biorepository using a configurable form to capture shipment and tracking information. Each item received in the shipment can be scanned and placed into a position in a storage container. A configurable form enables information to be quickly and efficiently recorded about each item. The first available position will be automatically highlighted. The operator can select the desired position and enter the specimen number or scan it directly from a barcode reader. As an alternative, the identifier may also be the one supplied by the originator. After the specimen has been stored, the focus will automatically move to the next available position for continuation of the work process. The screenshot below shows the storage dialog screen used to place a sample into a box. Scan field to record placement of biospecimen in next open position. Configurable display of information about the storage location. Configurable form to record and display information about the item being stored. Storage Location Management LabWare s Storage Location Manager provides a rich graphical interface that displays your storage location hierarchy. The interface provides a convenient way to visualize fully customer configurable storage locations and to quickly identify available storage space at any level of the hierarchy tree. Various menu options enable authorized users to move specimens and/or containers and to manage the storage location. LabWare 4

5 The screenshot below depicts a structured freezer location. Tree view of storage hierarchy. Configurable graphical information display about the location and the stored objects in the location. Specimens can be placed into storage locations by simply navigating to the appropriate node in the storage location hierarchy and using the add object function. Alternatively, Storage Location Manager provides a powerful feature to identify free storage locations based on criteria supplied by the end-user. For example, at the user s request, the system can perform an automated query to identify free, contiguous storage space for 4 specimens requiring storage at -20 Degrees C. Specimen Processing and Quality Control LabWare s configurable workflow management tools provide capabilities to manage all aspects of biospecimen processing and quality control, including for example: Aliquoting Nucleic acid extraction and analysis. Genotyping, gene expression, tissue microarrays, and sequencing. Cell line establishment and maintenance. LabWare 5

6 LabWare s unique folder technology lies at the heart of workflow management. Folders provide a customer configurable way to select sub-sets of samples and create paperless work lists for preparation, testing, result entry, or result review and approval, pull lists, packing, distribution, or disposal. Folders may be set to dynamically refresh, always displaying updated and accurate information for optimized user interaction with the system. The following screen capture shows the various components of a folder: The left pane displays the samples that meet the search criteria for the folder- e.g. samples pending for aliquoting and storage. Configurable menu options. Configurable tabular displays of detailed information about the selected sample and its existing aliquots. Distribution Request management Researchers request specimens from the biorepository to support their research efforts, and the LabWare solution provides the means to track these requests using a structured request management workflow. Requests are uniquely numbered and have their own lifecycle, enabling automated interaction between the requester and the other personnel and processes involved in the biorepository s operation. LabWare provides the flexibility to conditionally require that a request be subject to a formal approval, e.g. by a manager. A biorepository manager can then review the requirements necessary to fulfill the request, subsequently resulting in requests reaching a ready for check-out status. Biorepository staff can then be provided with a picklist to show specimen locations enabling the items to be efficiently pulled, packed, and shipped. Each of these steps can be managed and documented in the system. The screenshot below shows the distribution request dashboard where whenever a workflow step is selected (e.g. approve sample request), the screen refreshes with the list of requests that are pending for execution of the selected workflow step and the task list updates with tasks that are relevant for the selected workflow step. LabWare 6

7 List of requests that are pending for the selected workflow step - e.g. Approve Sample Request. Detail information for the selected request. Task list for the selected workflow step- e.g. Approve Sample Request. User Dashboard, Query, Charting, and Management Reporting LabWare open architecture and native tools enable easy access to information in the LIMS. Configurable dashboards provide an at a glance view of key metrics and status information in tabular or graphical format to each user. The majority of end-user functions that serve to query and report biorepository data are accessed via configurable menu or dashboard driven options. A menu of pre-configured reports is provided with the LabWare solution. A user is able to choose the required report format and may respond to any run-time prompts for additional or qualifying information. Data export routines can be set-up as menu driven options or to be run automatically, based on a configured schedule, and distributed to a distribution list via hard copy, fax, or . A configurable ad-hoc query tool provides additional flexibility for data extraction and export. LabWare LIMS also offers seamless integration of Northwest Analytics (NWA) Quality Analyst controls, which provide statistical quality control charting and trend analysis tools directly within the LabWare system. Contact us today to learn more about how LabWare will help improve your biorepository operations. LabWare 7

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