-------------------------------------------------------

Visit amazon.com for purchasing the book..

Online Donations

Please Donate If You feel this site is good and knowledge
resource of books or literature:

https://www.akshayapatra.org/onlinedonations

You can help the site by posting and/or telling your friends+colleagues about this place :)
Before God we are all equally wise - and equally foolish-Albert Einstein
Get your own Wavy Scroller
(Knowledge is not power; the ability to use that knowledge is power )

© Copyright 2009 Scientist. All rights reserved.

Disclaimer: Scientist-At-Work does not store any files on its server. We only index and link to webpages on, and provided by, other third-party websites.

"Use your head - I did!"

Sunday, June 28, 2015

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

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

This guide delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with FDA regulations related to international computer validation in the pharmaceutical industry. The guide shows how to comply with computer systems validation requirements, while highlighting and integrating Part 11 requirements into the entire computer validation program. Regulatory compliance is placed within the context of quality assurance, and the importance of integrating validation into the system life cycle using a structured top-down approach is stressed. Information is applicable to computer systems for pharmaceuticals, cosmetics, food, and medical device applications.
Year: 2004
Edition: 1
Language: English
Pages: 287

No comments: