Nonclinical & Laboratory (GLP)
Reconstructable safety studies, independent QA, and controlled archiving.
Good Laboratory Practice exists so a non-clinical safety study can be reconstructed years after it ran. The pillars inspectors probe are the independence of the quality assurance function and the integrity of archiving — if the raw data and the QA sign-off cannot be trusted, neither can the study.
The observable evidence a practitioner — or an inspector — would expect at each maturity level. Drawn from the assessment questions themselves.
How are GLP study data and archiving controlled?
Raw data retained informally; archiving is inconsistent
Archive SOP exists; QA inspections are irregular
Independent QAU, master schedule, and controlled archiving per 21 CFR 58 / OECD GLP
Validated archival with ALCOA+ controls and periodic archive-integrity checks
Validated e-archive with continuous ALCOA+ monitoring and predictive archive-integrity verification
How independent is quality assurance from study conduct and operations?
QA and operations share personnel and reporting lines
QA nominally separate but under operational pressure
Independent QA function with defined authority and escalation
QA independence reinforced by metrics reported to senior management
A quality culture with structurally guaranteed QA independence; QA performance is benchmarked and reported to the board
- ›The QA function is not independent of study conduct and operations.
- ›Raw data and specimens not archived under controlled, reconstructable conditions.
- ›Study plans and amendments not properly authorised; deviations undocumented.
- ›Missing master schedule or incomplete study records (21 CFR 58 / OECD GLP).