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Roadmap ISO 9001 Clause 8.5.6 — Control of Changes
ClearVue Change Control
ECN-lite change workflows — reviewed, approved, and recorded.
Lightweight engineering/quality change control: raise a change, route it through review and approval, link it to the affected documents and CAPAs, and retain the record. The Scale-tier differentiator that connects CAPA Advanced to controlled change.
Key Capabilities
- ✓ Change request intake with impact and affected-item linkage
- ✓ Configurable review and approval routing on the workflow engine
- ✓ Linkage to controlled documents, CAPAs, and affected processes
- ✓ Full audit trail of the change from request to closure
- ✓ Retained change record as documented information
How This Satisfies ISO 9001 Clause 8.5.6
Clause 8.5.6 requires organizations to review and control changes for production or service provision to the extent necessary to ensure continuing conformity. ClearVue Change Control produces the documented review, approval, and record of changes that the clause requires.
Works With
See Change Control in Action
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