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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. Approval requires five named impacts — validation, training, labeling, regulatory and supplier, the last three each a Yes or No with its rationale — and a change is linked to the controlled documents it revises, so it cannot close while retraining on them is still open.
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
- ✓ Five required impacts: validation, training, labeling, regulatory and supplier
- ✓ Two-signature control: approval and verified closure
- ✓ Segregation of duties between approver and closer
- ✓ Links a change to the documents it revises; closure waits for their retraining
The whole quality system shares one audit trail.
Change Control plus thirteen more modules — connected, Part 11, validation package included.
Explore the rest of the suite