Commissioning and Qualification · C&Q
A head start on commissioning and qualification.
Validation begins before turnover, because the data is already there and already checked.
C&Q usually waits for the pack. With access to vendor and trade contractor data as it is captured, validation checks can start well ahead of turnover. Sign-offs lock the data from editing, and anything that changes afterwards raises a flag with the people who signed it.
Start before the pack lands
C&Q teams work from construction and vendor data as it arrives rather than waiting for a completed turnover pack to be accepted.
Validated data stays validated
A validation sign-off locks the record. If anything downstream changes, the people who signed it are told rather than finding out at the audit.
Compliant from the first entry
Electronic records and signatures meet 21 CFR Part 11 and Annex 11 from the day work starts, so nothing has to be retrofitted to a GMP standard later.
After handover, the qualification record stays with the facility. The reference point for every requalification that follows.
