Towards a Unified Laboratory Informatics Platform STARLIMS SCIENTIFIC DATA MANAGEMENT SYSTEM

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1 Towards a Unified Laboratory Informatics Platform STARLIMS SCIENTIFIC DATA MANAGEMENT SYSTEM

2 INTEGRATING LIMS AND SDMS INTO A SINGLE PLATFORM INCREASES THE UTILITY, VALUE, AVAILABILITY AND LONGEVITY OF THE ORGANIZATION S INFORMATION RESOURCES.

3 STARLIMS Scientific Data Management System (SDMS) is the first product of its kind that is fully integrated into a Laboratory Information Management System (LIMS). The advantages of integrating all scientific and laboratory information into a single application are far-reaching: enhanced availability, protection of data and intellectual property, elimination of duplicate searches and streamlined information management throughout the organization. All this is attained with no need to develop and manage expensive interfaces. Designed to meet stringent regulatory requirements, STARLIMS SDMS is an ideal solution for capturing and managing data from analytical instruments and business applications: instrument output files, certificates of analysis and reports, product specifications, standard operating procedures (SOPs), and more. As a fully service-oriented application, STARLIMS SDMS makes information available to any authorized user with a standard web browser. Any document can be retrieved or stored via Microsoft Office applications, once the Select from SDMS and Save to SDMS custom buttons have been inserted.

4 The processes of STARLIMS SDMS can be summarized in f Step 1: Capture Seamless data capture and report generation throughout the LIMS lifecycle Files generated during the LIMS workflow including reports, documents, multimedia, images are stored transparently and seamlessly in the SDMS repository. In addition, STARLIMS SDMS automates content capture by polling preconfigured data sources, such as instrument data stations, e mailboxes, etc. This function is performed by the SDMS Grabber, which monitors operating system file creation events; upon file creation, it immediately moves the file to the secure, CFR Part 11 compliant SDMS repository for further processing. Files can also be saved directly to the STARLIMS SDMS repository by using custom buttons in Microsoft Office applications. Step 2: Parsing Artificial Intelligence streamlines content extraction STARLIMS uses unique Artificial Intelligence algorithms to process unstructured documents in an automated manner. STARLIMS SDMS extracts content from the document and stores it together with the relevant metadata tags. This process transforms unstructured data to an XML format that is both standardized and highly accessible. Based on the values of the metadata tags, the file is routed to a workflow. Subsequently, a link to the document is created within the appropriate STARLIMS module, and in the case of instrument outputs, the results table is updated with results parsed from the captured files. Before being able to automate the parsing and routing of documents, STARLIMS SDMS is trained to: Identify the file source (Varian Galaxy, Chemstation, Finigan GCMS, SOP, COA from vendors, etc.) Extract the appropriate metadata and content from the file (sample ID, instrument name, operator) and the results table (peak name, retention time, amount units) Map extracted data to a user-configured XML format, also referred to as the Unified XML Define routing directions, for example: All files captured from the CDS need to be reviewed prior to updating the LIMS results table All method SOPs need to be reviewed by lab manager, QC and approved by QA prior to becoming an active method in STARLIMS What makes this parsing approach unique is the application of Artificial Intelligence (AI) in the creation of the parsing routines. STARLIMS SDMS will automatically attempt to identify the following key document components (see screen capture at left): Identification tags - words that always appear in the target document and are used to determine the file source. Key words (green)- these are label value pairs used to populate the metadata tags. Table (yellow)- the parser automatically identifies table structures, such as peak tables. Charts(purple) - the parser identifies charts that need to be extracted, such as chromatograms, etc.

5 our steps: Any inaccuracies in the parsing of the unidentified document can be adjusted with simple drag-and-drop manipulations, and the SDMS will automatically follow the most recent update to the parsing routine when processing files. This approach renders the laborious task of producing parsing scripts trivial, greatly reducing time required and eliminating the need to learn complex parsing applications. Step 3: Workflow Manager Standardizing processes and ensuring regulatory compliance Using the Workflow Manager allows documents to be created, reviewed, modified and approved within a controlled environment that meets regulatory requirements. Documents are routed to a workflow either automatically by the parser or manually by attaching a document to a specific workflow ID. The workflow editor shown below allows custom workflows to be defined for the various document types and to specify the routing rules. Each creation, recreation and edit of the document creates a new version and the integration of the Documentum Document Management system means that each version can be saved and maintained. Each document is also digitally signed ensuring that a complete audit trail of changes is available. Users are made aware of workflow steps outstanding for them through the STARLIMS SDMS user interface; or through the inclusion of a real-time reminder within the STARLIMS V10 dashboard. Step 4: Secure Retrieval and Reporting Access is limited to authorized files only The ability to efficiently extract and use information that has been collected is the key to unlocking its value. STARLIMS SDMS allows information to be efficiently searched and retrieved based on metadata tag values. An intuitive navigation wizard allows users to define the navigation route. Two examples would be: 1. Show me documents belonging to water samples Narrow the search to a specific date range Narrow the search to documents tested by GC Narrow the search to documents where test= Btex 2. Show me Spec documents for Aspirin Narrow the search to Version 2 Routinely used navigation routes may be stored, eliminating the need to define the search criteria each time. The active security monitor allows users to navigate only to files they are authorized to access. There is full integration with Microsoft Desktop products that allows comprehensive reports to be generated in Word, Excel and PowerPoint documents. In addition, when integrated with a product such as Documentum, all the original files are available and may be retrieved using the built-in full text search capabilities of this widely used document management system.

6 STARLIMS SDMS - Typical USES The Project Management Tool promotes collaboration across the enterprise Collaboration in Research and Development Projects - STARLIMS SDMS works with the company s project management tools to strongly promote collaboration in research and development projects. R&D projects require collaboration between multiple resources and easy access to data generated by colleagues. STARLIMS project management tools enable scheduling tasks that are executed collaboratively by several resources. SDMS seamlessly collects all the documents generated during the completion of these tasks, creating a coherent picture of the entire R&D project. This is a major step forward in realizing the full value of this research and development work, and making it available throughout the organization. Instrument Integration - Using STARLIMS SDMS, data can be captured from any instrument that outputs a file of known structure, whether it is a single result, multiple results for a single sample or multiple samples. Required information can be extracted to unified XML, (which also allows the storing of graphical images) and imported to other systems. In addition, the original file can be stored using the content management functionality and the document can be recreated using XML. This provides not only instrument integration but also a mechanism of storing the information in a format-neutral way ensuring the long-term availability of critical information. Certificates of Analysis and Reports - Materials supplied to the laboratory or organization may come with Certificates of Analysis from the manufacturer. If these are supplied in electronic format they can be automatically processed and stored. This may include extraction of relevant test data and results and automatic import of that information into any system that requires it, for example LIMS, ERP or other manufacturing type systems. The same type of process can be used for Certificates of Analysis and reports generated by the laboratory. Product Specifications - Where an organization uses product specifications in the manufacturing process, maintaining, managing and updating those specifications can be a problem, especially in a global multi-site environment. The specifications need to be created, updated, approved and distributed. The workflow manager can be used to manage the review and approval mechanism. On approval the specification details can be converted to the XML format and as soon as this is done they become available for automatic upload to any system that requires the information. Standard Operating Procedures (SOPs) - SOPs and methods are managed in much the same way as product specifications. Workflow management can control the creation, review and approval; and on approval data can be extracted, processed and made available as required. Knowledge Management - Once file and document management has been implemented using the STARLIMS SDMS the data and information is available within a single unified system. This makes Knowledge Management a real possibility, allowing simple access to all the data and information created and used by the laboratory. STARLIMS Corporation 4000 Hollywood Blvd. #515S Hollywood, FL USA Tel: Fax: Regional Centers North America Tel: Latin America Tel: Europe Tel: Asia Pacific Tel: Copyright 2008 STARLIMS Corporation. All brand names and product names used here are trademarks, registered trademarks or trade names of their respective holders. STARLIMS is a registered trade mark of STARLIMS Corporation.