Service 08 / 18 · Qualification & Validation (CQV)
From Requirement to Verified Performance.
Validation is planned at the start of the project, not assembled at the end. A risk-based CQV approach links the URS to design review, DQ, FAT, SAT, commissioning, IQ, OQ and PQ, so each requirement is traced to a test. Protocols, execution records and reports are prepared for approval by the owner’s quality unit.
Engineering phases
Where this service fits
06 / 09 phases in scope
- 01Feasibilitynot in scope
- 02Conceptnot in scope
- 03Basic EngineeringIn scope
- 04Detailed EngineeringIn scope
- 05ProcurementIn scope
- 06ConstructionIn scope
- 07CommissioningIn scope
- 08ValidationIn scope
- 09Operationnot in scope
Scope
What the service covers
- 01Validation Master Plan and CQV strategy
- 02User requirements and traceability
- 03Risk and impact assessments
- 04DQ, IQ, OQ and PQ protocol preparation and execution
- 05FAT/SAT and commissioning documentation
- 06BMS/EMS qualification support
Method
From inputs to deliverables
INInputs
05 items- I01Process and product requirements
- I02Design documents and P&IDs
- I03Vendor documentation and FAT records
- I04Owner quality procedures
- I05Applicable GMP guidelines for target markets
WORKActivities
05 items- W01System boundary and impact assessment
- W02Risk assessment of critical aspects
- W03Protocol preparation and review
- W04Test execution and evidence collection
- W05Deviation management and reporting
OUTDeliverables
05 items- D-08.01Validation Master Plan (VMP)
- D-08.02User Requirement Specification (URS)
- D-08.03IQ/OQ/PQ protocols and reports
- D-08.04Requirements traceability matrix
- D-08.05Deviation log and summary report
Technical detail
Validation documentation
Contents · 06
01 / 06
Validation Master Plan
- Systems in scope and their classification
- Roles and approval responsibilities
- Lifecycle approach and sequencing
- Acceptance and handover criteria
02 / 06
Risk assessment
- System impact assessment
- Critical aspects and critical design elements
- Test scope scaled to risk
03 / 06
Traceability matrix
- Each URS item linked to design and test
- Coverage gaps visible before execution
- Status tracked through to closure
04 / 06
Protocols & reports
- Test procedures with defined acceptance criteria
- Execution records and objective evidence
- Summary reports for owner approval
05 / 06
Deviation tracking
- Recording and impact evaluation
- Root cause and corrective action
- Closure before system release
06 / 06
Commissioning documentation
- Commissioning plans and checklists
- Start-up and balancing records
- Leveraging commissioning evidence into qualification
Sequence
The CQV lifecycle
Each step builds on the evidence of the one before it, from the first requirement to handover.
01 / 10URS
User Requirements Specification
Defines what the system must do, in terms the owner can verify later.
Select a step to read what it involves.
URS
User Requirements Specification
Defines what the system must do, in terms the owner can verify later.
DESIGN REVIEW
Design Review
Checks the evolving design against the URS and GMP expectations before it is fixed.
DQ
Design Qualification
Documents that the final design meets every requirement in the URS.
FAT
Factory Acceptance Testing
Tests equipment at the vendor’s works so issues are corrected before shipment.
SAT
Site Acceptance Testing
Confirms equipment performs on site after delivery and connection.
COMMISSIONING
Commissioning
Starts up, adjusts and balances systems so they operate as designed.
IQ
Installation Qualification
Verifies that systems are installed as specified, with correct components and documentation.
OQ
Operational Qualification
Verifies that systems operate within defined limits across their operating ranges.
PQ
Performance Qualification
Demonstrates consistent performance under actual or simulated operating conditions.
HANDOVER
Handover
Transfers qualified systems and their records to the owner’s operations and quality teams.
Deliverables
Typical documents and outputs
- D-08.01Validation Master Plan (VMP)
- D-08.02User Requirement Specification (URS)
- D-08.03IQ/OQ/PQ protocols and reports
- D-08.04Requirements traceability matrix
- D-08.05Deviation log and summary report
Services
Related services
- 06
Process Utilities
Steam, air, gases, water and drainage systems sized and specified for regulated production.
Support can include validation master planning, URS support, design qualification, FAT and SAT support, IQ/OQ/PQ protocol development and execution support, and traceability between requirements and test evidence.
Next step
Planning a pharmaceutical project?
Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.
+20 101 171 1700