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21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Format Post in Computer BY Orlando Lopez

084932243X Shared By Guest

21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry Orlando Lopez is available to download <table><tr><td colspan="2"><strong style="font-size:1.This material is available do download at niSearch.com on Orlando Lopez's eBooks, 2em;">21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry</strong><br/>Orlando Lopez</td></tr> <tr> <td><b>Type:</b></td> <td>eBook</td> </tr> <tr> <td><b>Released:</b></td> <td>2004</td> </tr> <tr> <td><b>Publisher:</b></td> <td>Informa Healthcare</td> </tr> <tr> <td><b>Page Count:</b></td> <td>287</td> </tr> <tr> <td><b>Format:</b></td> <td>pdf</td> </tr> <tr> <td><b>Language:</b></td> <td>English</td> </tr> <tr> <td><b>ISBN-10:</b></td> <td>084932243X</td> </tr> <tr> <td><b>ISBN-13:</b></td> <td>9780849322433</td> </tr> </table> 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.21 CFR 11: Complete ... Textbook 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.

21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

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