Validation Support & Testing

With our GMP, GAMP & Annex 11 expertise, we can help with all your validation & testing requirements

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 robust 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
  • 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.

 

"As regards Software Development Process in supplying to FDA regulated industry, in my experience Millennium Software's quality standards and compliance are second to none."                    

- Pfizer Ireland's Validation Team Leader for Pfizer's Global Enterprise Management System (P-GEMS), Elizabeth Doody, Director EM Quality Control

 

Contact us now to discuss your Validation requirements.

 

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