21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Material type:
TextPublication details: Boca Raton CRC Press 2004Description: 243pISBN: - 9780849322433
- 338.476 LOP
| Item type | Current library | Item location | Collection | Call number | Status | Date due | Barcode | Item holds | |
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Reference Book
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NIMA Knowledge Centre | 7th Floor Silence Zone | Reference | 338.476 LOP (Browse shelf(Opens below)) | Not For Loan | P0001927 |
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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 regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
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