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(Ebook) 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry by Orlando Lopez ISBN 9780849322433, 084932243X

  • SKU: EBN-1121684
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4.5

11 reviews
Instant download (eBook) 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry after payment.
Authors:Orlando Lopez
Pages:287 pages.
Year:2004
Editon:1
Publisher:Informa Healthcare
Language:english
File Size:2.96 MB
Format:pdf
ISBNS:9780849322433, 084932243X
Categories: Ebooks

Product desciption

(Ebook) 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry by Orlando Lopez ISBN 9780849322433, 084932243X

This guide delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with FDA regulations related to international computer validation in the pharmaceutical industry. The guide shows how to comply with computer systems validation requirements, while highlighting and integrating Part 11 requirements into the entire computer validation program. Regulatory compliance is placed within the context of quality assurance, and the importance of integrating validation into the system life cycle using a structured top-down approach is stressed. Information is applicable to computer systems for pharmaceuticals, cosmetics, food, and medical device applications.
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