Computer Systems Validation

The requirements for Validation can make deploying and improving systems more difficult for the Regulated Industries.  We can help.

We have many years of experience, and a well-proven track record in Computer Systems Validation (CSV), working with GMP applications across a wide range of platforms and operating systems.  We have developed a sophisticated GAMP-compliant methodology that ensures efficiency and integrity of the validation process and documentation, and we provide a complete end-to-end service.  We can provide:

  • A Validatable development process
  • A broad experience of the requirements of the regulated industries
  • 21CFR11 expertise
  • A Risk-based approach
  • System Validation Documents:
    • Validation Master Plan (VMP)
    • Validation Plan (VP)
    • User Requirements Specification (URS)
    • Functional Requirements Specification (FRS)
    • Software Requirements Specification (SRS)
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • Risk Assessment
    • Validation SOPs
  • Traceability of components from Requirements to final objects
  • Lean Validation approach - consistent with your risk posture
  • Validation Protocol execution and deviation resolution


Whether you need some high-level guidance to navigate the realities of GMP, or just need someone to help design or run tests, we can provide the expertise you require.