21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Orlando Lopez
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.
Kategori:
Tahun:
2004
Edisi:
1
Penerbit:
Informa Healthcare
Bahasa:
english
Halaman:
287
ISBN 10:
084932243X
ISBN 13:
9780849322433
File:
PDF, 2.96 MB
IPFS:
,
english, 2004
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