Laboratory Data and Information Management

Customer: A large biopharmaceutical company with multiple products that are already on the market and 10’s of products in development or clinical trials

Problem: The client had a mixed environment that consisted of multiple LIMS systems and  that could be integrated  in a compliant environment.

Solution: Tribiosys was retained by the Director of Information Technology to analyze the current state architecture and provide a road map that would optimize both inter- and intra- department data flow. The implementation road map was to be compliant with the 21 CFR Part 11 (electronic records and electronic signatures) and Good Laboratory Practices (GLP). To achieve this goal, an exhaustive analysis of all aspects of laboratory scientific research and the respective workflows was conducted. This included analysis of data access, generation, transfer, transformation, analysis, security and archival. Data sources included, in-process assay data and instrument data that were currently stored on network drives and local hard drives. As a result, a number of workflows and processes were identified that exposed the client to high risk of cGLP non-compliance and consequently were a source of reduction in efficiency and productivity. To fully integrate data from all varied sources and enable the client to achieve it’s integrated data needs, Tribiosys systematically analyzed all current processes, applications and instruments.  Tribiosys next  identified the optimal mix of LIMS systems (Nautilus, Watson, Provantis, SQL LIMS etc.) that would integrate with their in-house scientific data management systems (SDMS) and developed an extensible service-oriented architecture best suited to the clients current needs and future demand to support a 21 CFR part 11 compliant integrated environment.  The implementation plan developed by Tribiosys for the data architecture provided a conceptual framework for the optimization of the drug development process and its eventual integration into a corporate-wide decision support and knowledge management infrastructure. The desired solution met the clients’ current needs and was flexible enough to incorporate future requirements such as CRO communication, laboratory automation, data repository integration and electronic capture of process data.

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