Validation Compliance Annual : 1995

ISBN-13: 9780824794590 / Angielski / Twarda / 1995 / 1110 str.

International Validation Forum; Validation Forum Validation Forum; International Validation Forum

Opis

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 system validation. Case studies of real-world situations are provided.

Spis treści

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.

O autorze

International Validation Forum