Overview
- Multi-framework compliance engine with pharma GxP assurance, auditor portal, and exportable evidence packs.
- Always Audit-Ready. Continuously Compliant.
← ResourcesCapability Brief
Compliance & Pharma GxP Datasheet
Multi-framework compliance engine with pharma GxP assurance, auditor portal, and exportable evidence packs.
Problems We Solve
- Audit evidence scattered across tools → Unified compliance reports and export catalog
- Pharma validation requirements → IQ/OQ/PQ validation records and GxP Assurance wizard
- External auditors need read-only access → Grant-scoped Big 4 auditor portal
- Immutable audit trail required → Verify and export audit chain integrity
Key Capabilities
- Multi-framework compliance engine
- SOX, GDPR, HIPAA, PCI exports
- ISO 27001 and NIST reports
- IQ/OQ/PQ validation records
- 21 CFR Part 11 e-signatures
- Change freeze capability
- Grant-scoped auditor access
- Read-only portal
- GxP audit pack ZIP export
Outcomes
- 98%+ — Compliance Scores
- 1-Click — Audit Pack Export
- 21 CFR — Part 11 Ready
- Zero — Audit Scramble
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