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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.
This annual publication addresses the critical need for understanding and implementing validation compliance within the evolving regulatory landscape of 1995. It provides a comprehensive resource for professionals navigating the complexities of computer systems validation across various industries. The book aims to consolidate essential information on regulations, guidance, and best practices, offering practical tools and insights for achieving and maintaining compliance.
This volume serves as a crucial reference for professionals in fields requiring stringent regulatory compliance, particularly concerning computer systems. Its focus on the 1995 regulatory environment, including key agencies like the FDA and EPA, positions it as a historical snapshot of compliance standards. The inclusion of case studies and practical tools suggests its utility for both understanding existing frameworks and implementing them effectively.
Page Count:
1200
Publication Date:
1995-02-17
Publisher:
CRC Press
ISBN-10:
0824794591
ISBN-13:
9780824794590
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