The challenge
The client was verifying flow accuracy manually with gravimetric benches, taking 40 minutes per device and producing paper records that were difficult to trend or audit. A planned capacity increase meant the process would not scale, and an upcoming FDA inspection required electronic records with audit trails.
Our approach
We developed the user requirement specification with the client's quality team, then designed a six-station test system with precision gravimetric measurement, pressure sensing for occlusion alarms and barcode-driven device identification. Software was developed under a GAMP 5 category 5 lifecycle with role-based access, electronic signatures and full audit trail. We executed FAT, SAT, IQ, OQ and PQ with the client and trained operators and QA personnel.
The outcome
Test time per device fell to under eight minutes, test records became fully electronic and trendable, and the system passed regulatory inspection with no observations. The client has since ordered a second system for a new product family.
Representative engagement. Client identity and certain project details are withheld or generalised under confidentiality agreements.