Pharma GxP Assurance Pack
- IQ/OQ/PQ validation records and go-live checklist
- 21 CFR Part 11 e-signatures and immutable audit chain
- External auditor portal — read-only, grant-scoped Big 4 access
- GxP audit pack ZIP export from P2P/O2C campaigns
← ResourcesCapability Brief
GxP Capability Brief
Pharma-ready IGA + GRC with FDA, HIPAA, 340B, and 21 CFR Part 11.
Pharma-Specific Controls
- P2P: FDA supplier qualification, track & trace, cold chain, expiration
- O2C: 340B pricing, patient assistance programs, adverse event escalation
- PAM: Firefighter session replay for GxP inspections
- Self-hosted AI — no production data sent to cloud LLM APIs
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