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Pharmaceutical Computer Systems Validation
Quality Assurance, Risk Management and Regulatory Compliance
Guy Wingate
Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:
- GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
- 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
- the indirect developments from FDA/EU/Japan regulators and industry
- the role of QA department, and internal and external suppliers
- the integration of computer systems validation into single overall approach for wider system
- practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
- managing outsource partners and handling legacy systems
- topical issues uncovered by regulatory authorities including US FDA
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