Pharmaceutical

Pharmaceutical automation is judged on the paperwork trail as much as the running system. We work to GAMP 5 categories from the start: URS, FS and DS written before logic, traceability matrix maintained through the build, and IQ/OQ/PQ protocols executed and signed rather than reconstructed afterwards. Retro-fitting that documentation onto a finished system costs more than writing it alongside — and auditors can tell the difference.

In the system itself, 21 CFR Part 11 sets the shape: unique user accounts with no shared logins, an audit trail that cannot be edited or cleared from the HMI, electronic signatures on batch-affecting actions, and time synchronisation across every node so records reconcile. Change control continues after handover, because a validated system that gets an undocumented logic patch in year two is no longer validated.