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 Only the current approved version circulates; every superseded one stays retrievable.
EU GMP Ch. 1 · ICH Q10
Deviation Management
Deviations are numbered per workspace, risk-assessed at logging, investigated with structured root cause analysis, and dispositioned. Where the investigation warrants it, a CAPA is raised with the linkage preserved.
What it does
- Sequential numberingDEV-001 onward, scoped to your workspace
- Risk assessmentClassified at the point of logging
- Root cause analysisStructured rather than free text
- Escalation to CAPALinked, without rekeying the investigation
Records it produces
- The deviation, its risk class and its disposition
- Investigation and root cause
- Any CAPA it raised, and that CAPA’s outcome
- Full attributed timeline
Where it sits
What it triggers, and what triggers it
A deviation is the start of the chain an inspector follows: investigation, CAPA, effectiveness.
CAPA
Raised from the investigation with the linkage preserved. No rekeying, no orphaned action.
Document Control
A deviation that ends in a procedure change references the document it changes.
Internal Audits
Findings from an audit can be logged and investigated the same way.
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.
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.