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 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.
Price: 94.82 AUD
Location: Hillsdale, NSW
End Time: 2024-11-26T22:43:08.000Z
Shipping Cost: 25.96 AUD
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Restocking fee: No
Return shipping will be paid by: Buyer
Returns Accepted: Returns Accepted
Item must be returned within: 30 Days
EAN: 9780367394592
UPC: 9780367394592
ISBN: 9780367394592
MPN: N/A
Item Length: 25.2 cm
Number of Pages: 243 Pages
Language: English
Publication Name: 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Publisher: Taylor & Francis Ltd
Publication Year: 2019
Subject: Engineering & Technology
Item Height: 254 mm
Item Weight: 481 g
Type: Textbook
Author: Orlando Lopez
Item Width: 178 mm
Format: Paperback
