Computer System Validation

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GAMP 5 Category 4 Quality Management Computer Systems Validation Services


Our Methodology

Many regulated companies, such as those in life sciences, food and beverage, and the cosmetics industry, worry about time and resources required for software validation. For many of our customers, having a validation process which verifies that your systems are compliant and fit for purpose is critical to compliance with legislation and standards. Our validation methodology is designed to significantly reduce time and effort involved in your validation process. From developing your user requirements specification (URS) to performance qualification (PQ), we offer an end-to-end validation service to ensure you are compliant. We also help you set up a validation process so that when there are system upgrades or you need to make any changes to your processes, you can properly validate your systems in the future.

A thorough validation service

Our 5 steps process

  • Plan: Involves building / updating the user requirements specification (URS), functional specification and supplier assessment.
  • Build: The Installation Qualification (IQ)
  • Configure: The Configuration Specification (CS) and configuration plans.
  • Test: The Operation Qualification (OQ), includes administrator training, user training and on-boarding plans.
  • Review: The Performance Qualification (PQ), Standard Operating Procedure (SOP) review and change control.

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