Module 01
Audit Management
One engine for every audit type, supplier to self-inspection.
Three directions
- Conducted
- Audits you run — supplier sites, CMOs, testing labs, in-licensing due diligence.
- Hosted
- Audits run on you by regulators and customers.
- Internal
- Self-inspection against ISO 9001, cGMP, EHS and safety.
Twelve canonical types
Each with a default finding taxonomy and requalification interval, overridable per tenant.
| Audit type | Direction | Requalification |
|---|---|---|
| Regulatory Inspection | Hosted | Agency-native findings |
| Internal Audit / Self-Inspection | Internal | 12 months |
| In-licensing Due Diligence | Conducted | 24 months |
| Out-licensing / Customer-Hosted | Hosted | 24 months |
| API Site Audit (ICH Q7) | Conducted | 36 months |
| Excipient Site Audit | Conducted | 36 months |
| Packaging Material Site Audit | Conducted | 36 months |
| Finished Product / CMO Site Audit | Conducted | 24 months |
| GxP Misc Item Site Audit | Conducted | 36 months |
| External Service Provider Audit | Conducted | 36 months |
| External Testing Lab Audit | Conducted | 36 months |
| PSCI (ESG) Audit | Conducted | Five-pillar findings |
The lifecycle
- Plan
- Risk-based scheduling from requalification cadence and current risk posture.
- Prepare
- Scope, team and pre-reads, with public history attached.
- Execute
- Evidence captured on a phone, attached to its question.
- Report
- Findings graded against the type's taxonomy — GMP/CMMO, PSCI, agency-native, or yours.
- Close
- CAPA evaluated, certificate issued, ASL status updated.
Also in the module
- Auditor qualification
- Auditors are qualified and gated — no assignment outside a certified scope.
- External auditors, no licence
- Invite by link; one signup screen, then straight to mobile evidence capture.
- Checklist libraries
- Versioned question sets bound to audit types and standards.
- Audit RFQ
- Put an audit out to qualified third-party auditors, compare, award.
- Signed phase gates
- Scope locks once the intimation is signed.
See it against your own audit types
We will walk your twelve types, not a generic demo script.