21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
- ISBN-10
- 1135488754
- ISBN-13
- 9781135488758
- Category
- Medical
- Pages
- 287
- Language
- English
- Published
- 2004-01-15
- Publisher
- CRC Press
- Author
- Orlando Lopez
Description
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. The author introduces supporting technologies such as encryption and digital signatures and places
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