SERVICES & SOLUTIONS
	> GMP EXPERTISE

We have many years experience, and a well proven track record, 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

"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)