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Item Details
| Title:
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21 CFR PART 11
COMPLETE GUIDE TO INTERNATIONAL COMPUTER VALIDATION COMPLIANCE FOR THE PHARMACEUTICAL INDUSTRY |
| By: |
Orlando Lopez |
| Format: |
Electronic book text |
| List price:
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£137.00 |
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We believe that this item is permanently unavailable, and so we cannot source
it.
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| ISBN 10: |
0203026772 |
| ISBN 13: |
9780203026779 |
| Publisher: |
TAYLOR & FRANCIS INC |
| Pub. date: |
15 January, 2004 |
| Pages: |
243 |
| Synopsis: |
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. |
| Illustrations: |
23 Illustrations, black and white |
| Publication: |
US |
| Imprint: |
CRC Press Inc |
| Returns: |
Non-returnable |
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