System Validation and Qualification (IQ/OQ/PQ): GAMP 5, EU GMP Annex 15
Full-scope equipment, computerized system and process validation services for the pharmaceutical, medical and food industries, using a GAMP 5 risk-based approach.
V-Model Lifecycle
We manage our projects according to the internationally recognized V-Model project lifecycle. All processes, from the design of systems and equipment through handover to the user, are documented and made traceable.
Process steps: URS (User Requirements) → FS (Functional Specification) → DS (Design Specification) → DQ (Design Qualification) → FAT (Factory Acceptance Test) → SAT (Site Acceptance Test) → IQ (Installation Qualification) → OQ (Operational Qualification) → PQ (Performance Qualification).
Critical Applications and Validation Guidelines
The validation of the systems we install is carried out aiming for full conformity with the regulations of international authorities.
Reference Standards
- GAMP 5: Risk-based approach to the validation of computerized systems.
- EU GMP Annex 15 (2015): European Good Manufacturing Practice rules on qualification and validation.
- FDA Process Validation Guidance (2011): The US Food and Drug Administration guidance on process validation.
- WHO TRS 937: World Health Organization validation guidelines.
Special Applications
- Water system validation: Staged water system validation according to USP <1231>, referred to as Phase I (2-4 weeks), Phase II (2-4 weeks) and Phase III (1 year).
- Clean steam validation: Non-condensable gases, dryness fraction and superheat tests according to the EN 285 standard.
- Temperature mapping: Thermal distribution studies for warehouses, autoclaves and incubators.
Deviation and Change Management
Deviations encountered in validation processes are investigated and reported in detail. CAPA (Corrective and Preventive Actions) plans are drawn up to resolve the deviations.
Every hardware or software change on the system is subject to approved "Change Control" procedures, and its effect on equipment and product quality is evaluated through risk analyses.
Documentation Structure
- Approved test protocols (IQ, OQ, PQ)
- Raw data and certificates (calibration, material, welding)
- Traceability Matrix
- Risk analysis reports (FMEA)
- Validation summary reports
Planning a project? Send us your flow rate, feed water source and target water quality to [email protected] — our engineers will reply with a technical proposal.