Pharmaceutical Computer Systems Validation. Quality Assurance, Risk Management and Regulatory Compliance

This text examines computer validation and verification principles and how to put them into practice. It reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. All 24 case studies from the first edition have been revised.

Topics:

• GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions
• ICH Guidance Q8, Q9, and Q10 expectations
• FDA cGMPs for the 21st Century Initiative and associated guidance
• PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
• WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• FDA/EU/Japan regulators/industry developments 
• QA and internal/external suppliers
• integration of computer systems validation into single overall approach
• common high, medium, and low risk issues
• partners and legacy systems