
New or modified production equipment
Qualify production systems and equipment using a risk-based approach
New or substantially modified equipment is approaching operational use. Scope, critical requirements, existing supplier evidence and responsibilities are not yet sufficiently aligned.
QMVP supports user requirements, risk assessment, qualification strategy and applicable DQ, IQ, OQ and PQ activities, including deviation assessment and closure.
An agreed qualification package identifies required testing and evidence, responsibilities and open points before operational use.
Possible deliverables
- User Requirements
- Risk assessment
- DQ/IQ/OQ/PQ protocols
- Qualification report