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 Only the current approved version circulates; every superseded one stays retrievable.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 §8.5.2 and §8.5.3
CAPA
Corrective and preventive actions carry owned action items and due dates, and cannot close until an effectiveness review is complete. That review is the artefact auditors ask for and the one most commonly missing.
What it does
- Action itemsNamed owners and due dates
- Effectiveness reviewRequired before closure
- Dependency mapAcross every linked record
- Source linkageBack to the deviation, finding or complaint
Records it produces
- The CAPA, its actions and their owners
- Effectiveness review and its verdict
- What raised it and what it resolved
Where it sits
What it triggers, and what triggers it
CAPA is where a deviation, a finding or a complaint becomes a change, and where the evidence that it worked is kept.
Deviation Management
The usual source. The deviation, the investigation and the CAPA stay linked in both directions.
Internal Audits
Audit findings raise CAPAs directly. Closure evidence lives on the CAPA.
Document Control
When the action is a procedure change, the CAPA references the new revision.
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.
Internal Audits
ISO 13485 §8.2.4
Programme planning, checklists, findings and closure evidence. Findings raise CAPAs directly; external auditors get scoped access.