Training Management
ISO 13485 §6.2
Role-based matrices, assignment straight from a controlled document, quizzes, and requalification tracked per person.
ISO 13485 §4.2.4
Document Control
Controlled documents move through enforced states. Only the current approved revision is in circulation, superseded revisions stay retrievable, and the history records every content edit, change request and approval transition.
What it does
- Lifecycle statesDraft, review, approved, effective, obsolete, with enforced transitions
- Version controlNew versions route through approval rather than going live directly
- Approval workflowsConfigurable per document type
- Periodic reviewScheduled with owner notification
- Training on effectivityBecoming effective can assign training automatically
Records it produces
- The current approved revision of any document
- Complete revision history with approver and date
- Change requests and their outcomes
- Who is trained on which revision
Where it sits
What it triggers, and what triggers it
A document becoming effective is where training starts and where the Officer’s findings land.
Training Management
Effectivity assigns the training. The trainee signs completion against that revision.
AI Compliance Officer
Findings are raised against a specific document and revision, and accepted into a change request or a new version.
Internal Audits
Checklists reference the controlled document, so the audit runs against what is actually in force.
The other modules
Everything else in the Compliance plan
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.
Internal Audits
ISO 13485 §8.2.4
Programme planning, checklists, findings and closure evidence. Findings raise CAPAs directly; external auditors get scoped access.