Stephen Robert Goldman

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1stbooks Library) Stephen Robert Goldman

Much has been written about "why" to validate. The Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry is an SOP-centric explanation of "how" to validate. Creating a state of sustainable compliance with FDA regulations including 21 CFR Part 11, Electronic Records; Electronic Signatures is daunting task. This handbook follows FDA guidelines and "Best Industry Practices" in defining the roles, responsibilities, and requirements of computer and computerized system validation for the pharmaceutical, biotechnology, and medical device industries. It details the requirements for Standard Operating Procedures and Protocols for User Requirements, Functional Requirements, Design Specifications, Installation Qualification, Operational Qualification, and Performance Qualification. 21 CFR Part 11 Assessment and validation gap analysis methods are prescribed to determine the state of compliance of systems with current regulation. The! first requirement of 21 CFR Part 11 is "Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records." This book explains how to comply with this and other requirements of 21 CFR Part 11.