Regulatory basis
Designed against the rules you are inspected on.
Controls are built into the database and the workflow, not added as a report at the end.
- 21 CFR Part 11
- Electronic records and signatures, re-authenticated with password and authenticator.
- EU GMP Annex 11
- Validated computerised system with a trigger-enforced, append-only audit trail.
- EU GMP Annex 22 (draft)
- Generative AI drafts and checks. It never takes a GMP decision. A named person does.
- ICH Q9(R1)
- Risk assessment with recorded scores and rationale, not subjective labels.
- ICH Q10
- Deviation, CAPA, change control and review as one pharmaceutical quality system.
- ALCOA+
- Attributable, legible, contemporaneous, original, accurate, complete and retained at the database layer.
Probity ships validation starting materials (URS, FS, DS, IQ, OQ, PQ, traceability). Site qualification, approved procedures and controlled release remain the licence holder's responsibility.
Evaluate Probity with your own synthetic case.
Evaluation sites run Probity on synthetic data with a local or cloud model. The model is qualified inside the product before it is used on any record.