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Validation Documentation

 

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
RTM example

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
Testplan 1-2-3
 
Risk & Quality Focus
  • FMEA on product flow
  • Failure mode identification
  • Mitigation actions
  • Focus on product quality
FMEA example:
Example of FMEA

 

 

 

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