Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance, Volume 1 (Drugs and the Pharmaceutical Sciences)

Computerized systems play a fundamental role in the development, manufacture, and supply of medical treatments.This is the third and thoroughly updated edition of the best-selling book dealing with validation and compliance of computer systems and software in the pharmaceutical, healthcare, and medical device industries. Features• Covers governance framework, roles and responsibilities, quality culture, project life cycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and opportunities for performance improvement. • Provides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice. • Focuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPs-complete with observations from inspections by the U.S.FDA and other regulators. • Discusses industry regulations and guidance, i