Probity QMS

Intelligent pharma QMS. AI-assisted, human-decided.

Deviations, investigations, CAPA and closure in one system. The AI helps your team find, check and draft. Your people make every decision and sign every record.

Audit trail
append-only
Signatures
Part 11
AI role
advisory only
A deviation moving through the Probity lifecycleReport, triage, investigation, root cause, CAPA, effectiveness and closure. The agent assists between stages; a person decides and signs at each gate.ReportDEV-2026-0418Triageseverity · QAInvestigationevidenceRoot cause5-whys · fishboneCAPACA + PAEffectiveness90-day checkClosurePart 11 signatures● agent assists between stages◎ a named person decides and signs

People decide

Every record is written and signed by a person. AI output is stored as evidence next to the decision, never as the decision.

Audit trail by design

Append-only audit trail enforced in the database. Electronic signatures bound to the record. Tenant isolation at the row level.

Final report with controls

The final deviation report is blocked until QA approval, closed CAPAs, an effective check and valid signatures exist. Then it is locked.

Probity QMS · Intelligent pharma QMS, AI-assisted and human-decided