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.
Additional
case studies -Laboratory Data and Information Management