Document Control
ISO 13485 §4.2
Enforced revision history, approval workflows and effective dates. Only the current approved version circulates; every superseded one stays retrievable.
ISO 13485 §8.2.4
Internal Audits
The audit programme, its plans, checklists and findings, through to closure evidence. External auditors can be given scoped, time-limited access rather than a copy of your quality system.
What it does
- Audit programmeAnnual schedule with planned audits
- ChecklistsExecuted against the plan
- FindingsClassified, assigned and tracked to closure
- Findings raise CAPAsWith linkage preserved
- External auditor accessScoped and time-limited
Records it produces
- The audit programme and its execution
- Findings, owners and closure evidence
- CAPAs raised from findings
Where it sits
What it triggers, and what triggers it
Audits read everything the other modules produce and raise CAPAs from what they find.
CAPA
A finding raises a CAPA with the linkage kept, so closure evidence is where the auditor looks for it.
Training Management
The training matrix and outstanding-training report are audited as records, not reconstructed.
Auditor role
Read-only, scoped to what you share, and time-limited. Their access is itself on the audit trail.
The other modules
Everything else in the Compliance plan
Training Management
ISO 13485 §6.2
Role-based matrices, assignment straight from a controlled document, quizzes, and requalification tracked per person.
Deviation Management
EU GMP Ch. 1
Logged, risk-assessed, investigated and dispositioned, with a controlled path into CAPA when the investigation warrants one.
CAPA
ISO 13485 §8.5
Owned action items, due dates, and an effectiveness review that must complete before closure.