Our approach
- Risk-based validation (GAMP 5)
- Early testing at FAT
- Leveraging supplier testing
- Lifecycle-driven validation
Full validation scope
- DQ - FAT - SAT - IQ - OQ
- Mechanical, functional & software
- Complete documentation coverage
What you get
- Validation Plan
- RTM
- FAT/SAT protocols
- IQ/OQ execution (some may leverage from FAT/SAT)
- Full documentation package
Example of RTM
Validation test examples
We validate directly against URS requirements, ensuring full traceability and compliance.
If IQ/OQ is included, test protocols are elevated to meet the following qualification standards.
Examples but not limited to:
- PLC / HMI functionality
- Vision systems & inspection
- Reject and Eject scenarios
- Alarms & workflows
- E-stop/power failure and backup/restore
- Interfaces & data flow
Example of Testplan
Risk & Quality Focus
- FMEA on product flow
- Failure mode identification
- Mitigation actions
- Focus on product quality
FMEA example:
