"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Table of Contents
Overview - behind validation, the regulatory world; government regulation - FDA regulation, EPA regulations, European union regulations; situational review - situational review by industry, situational review in the USA, international situational review; tools for validation - validation checklist, the use of an SDLC in system validation, data integrity and security, documentation - the SOP, electronic signatures, drug inspections, biologics inspections, medical device inspections, hazard analysis; field findings - FDA adverse findings, case study experience - sixteen theses; future developments - future developments. Appendices: glossary; validation bibliography.