SERVICES & SOLUTIONS
	> COMPUTER SYSTEMS VALIDATION (GMP) EXPERTISE

We have many years of experience, and a well proven track record in Computer Systems Validation, 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 process
• A broad experience of the requirements of the regulated industries
• 21CFR11 expertise
• A Risk-based approach
• System Validation Documents:
• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• Software Requirements Specification (SRS)
• Validation Master Plan
• 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 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."
- Elizabeth Doody, Director EM Quality Control and Pfizer Ireland's Validation Team Leader for Pfizer's Global Enterprise Management System (P-GEMS)

Contact us now on 021-497 9620 or at info@millsoft.ie to discuss your Software Validation requirements.