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21 CFR Part 11
- Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Engelsk
Bogcover for 21 CFR Part 11 af Orlando Lopez, 9780367394592
Specifikationer
Sprog:
Engelsk
Sider:
260
ISBN-13:
9780367394592
Indbinding:
Paperback
ISBN-10:
0367394596
Udg. Dato:
23 sep 2019
Størrelse i cm:
25,4 x 17,8
Oplagsdato:
23 sep 2019
Forfatter(e):

21 CFR Part 11

- Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Engelsk
Paperback 2019
Format:

Bog beskrivelse
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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Specifikationer
Sprog:
Engelsk
Sider:
260
ISBN-13:
9780367394592
Indbinding:
Paperback
ISBN-10:
0367394596
Udg. Dato:
23 sep 2019
Størrelse i cm:
25,4 x 17,8
Oplagsdato:
23 sep 2019
Forfatter(e):
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