A Fortune 500 life science organization desired to implement a multi-site, GMP validated Process Analytical Technology (PAT) system. This initiative was part of a parent project to align with its Pharma 4.0 initiative to embed digitalization into the manufacturing process. The project also needed to be accomplished in concert with multiple ongoing enterprise software portfolio implementations. The effort was performed simultaneously considering new site construction progress with facility construction dependencies as well as multiple 3rd party software integration requirements.
Lean Biologix partnered with our client to create a complete PAT Computer System Validation Package (CSV). This effort included all IT lifecycle documents required for producing a validated GMP system. Responsibilities ranged from risk assessment and initial requirements development to the complete validation testing packages for multiple sites. Lean Biologix was also responsible for management of all change control and documentation activities.
The effort included the following considerations and actions:
- Aligned System Requirements with Annex 11 and 21 CFR Part 11 GMP software standards
- Configured multiple instances of software across domains and geographic locations with high security requirements across multiple firewalls
- Managed client-vendor relationship to deliver customized functionality for a variety of PAT processes and equipment
Summary of Engagement
Lean Biologix managed the client PAT implementation reporting to overall program management to align project milestones with 3rd party teams. The team identified all key integration points within the overall program mapping software dependencies to ensure realistic development, testing, and implementation timelines. The Company delivered the final validated system along with final reports and full set of system lifecycle documentation within budget, on schedule. The project’s results demonstrated the value of the Lean Biologix approach and expertise with GAMP5 strategies and IT program management.