21 CFR Part 11

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21 CFR Part 11

Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Quality Assurance (QA) and Total Quality Management (TQM) Chemical, biotechnology and pharmaceutical industries Regulation of medicines and medical devices Computer applications in industry and technology

Author: Orlando Lopez

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Language: English

Published by: CRC Press

Published on: 15th January 2004

Format: LCP-protected ePub

Size: 2 Mb

ISBN: 9781135488758


Overview

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations.

Technologies

The author introduces supporting technologies such as encryption and digital signatures and places

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