Trinity began by conducting a detailed risk assessment for every component and process step, identifying how each piece of equipment could impact product quality, safety, and data reliability. The team mapped out a commissioning plan that aligned functional testing requirements with the level of risk, ensuring critical systems received comprehensive qualification while avoiding unnecessary duplicate testing.
A complete Data Integrity and Electronic Records Assessment was performed to confirm that all automated control systems complied with 21 CFR Part 11 requirements for secure electronic records. Trinity’s engineers carefully reviewed factory acceptance tests and site acceptance tests provided by equipment vendors, repurposing validated documentation where possible to accelerate the timeline.
To handle the complexity of qualifying multiple hose sizes and flow rates, Trinity implemented a bracketing strategy that validated only the most extreme operating conditions. By demonstrating that both minimum and maximum parameters performed reliably, the full operational range was covered efficiently without testing every possible combination. A detailed Requirements Traceability Matrix tied all testing back to user and regulatory requirements, providing clear evidence of compliance at every step.
Through close coordination with Advent’s engineering and quality teams, Trinity executed all commissioning and qualification activities within the tight timeframe, while maintaining full traceability and audit readiness.
