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Change Control
Controlled change with a documented impact assessment and dual sign-off.
ISO 13485 §7.3.9 · §4.2.4 (21 CFR Part 820, QMSR)
What it does
Raise, assess, approve, and close controlled changes to documents, processes, equipment, materials, or suppliers. The impact assessment captures validation impact and training impact, so a change never quietly bypasses the qualification or training it should trigger.
How Indelio handles it
A server-enforced lifecycle (Open → Assessment → Approved → Closed) with two electronic-signature gates: change approval and implementation-verified closure. Segregation of duties means the person who verifies and closes the change cannot be the one who approved it.
Key capabilities
- ✓ Structured impact assessment (validation + training impact)
- ✓ Two-signature control: approval and verified closure
- ✓ Segregation of duties between approver and closer
- ✓ Links changes to the documents and training they affect
The whole quality system shares one audit trail.
Change Control plus thirteen more modules — connected, Part 11, validation included.
Explore the rest of the suite