Scope, critical requirements, acceptance criteria, responsibilities and DQ/IQ/OQ/PQ evidence are not available in time or are inconsistent.
Production equipment
Qualify production systems and equipment using a risk-based approach
Direct technical support from user requirements and qualification strategy through DQ, IQ, OQ and PQ to a traceable final report.01URSRequirements
02RiskScope
03DQ · IQ · OQ · PQTesting activities
04AssessmentDeviations
05ReportConclusion
Typical project situation
When technical delivery is progressing but the qualification scope is still unclear.
A clear qualification scope and agreed testing activities reduce project delays and support a planned qualification conclusion before operational use.
Typical deliverables
- 01Qualification strategy or plan with scope and responsibilities
- 02User requirements, risk assessment and acceptance criteria
- 03Applicable DQ/IQ/OQ/PQ protocols and documented test results
- 04Assessed deviations and traceable open points
- 05Qualification report with final assessment
Approach
Four connected technical work steps.
Clarify the scope
Together, assess the equipment, process, interfaces, responsibilities and existing evidence.
Derive a risk-based scope
Translate requirements, risks and acceptance criteria into applicable DQ/IQ/OQ/PQ activities.
Execute and assess testing
Document protocols and results, assess deviations and keep open points transparent.
Document the conclusion
Consolidate evidence in the qualification report and create a traceable basis for decisions.
Collaboration and boundaries
Technical support with clear operator responsibility.
QMVP develops the required understanding of the equipment, process and interfaces in a structured collaboration with the technical owners. This establishes system boundaries, requirements, responsibilities and acceptance criteria; operator and approval responsibilities remain with the client.
Frequently asked question