Source: http://pi.campbellalliance.com/elearning/gxp-regulatory-series/gxp-regulatory-series-21-cfr-part-11/index.cfm
Timestamp: 2019-08-25 04:48:40
Document Index: 87456527

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Learning Solutions - GxP and Regulatory Series - 21 CRF Part 11
In August 1997, the FDA gave the industry a set of rules for electronic signatures and electronic records. It became 21 CFR Part 11: Electronic Signatures, Electronic Records. This course discusses why Title 21 of the Code of Federal Regulations Part 11, or "21 CFR Part 11" was developed, explains the role that Part 11 plays in the adherence to other sections of 21 CFR, and explores the general concepts of security in a Part 11 compliant system.
Describe how the need for regulations on electronic records led to the creation of Part 11
Identify the Part 11 regulations and their scope
Explain how Part 11 relates to other sections of 21 CFR
Describe why Part 11 compliance makes both legal and business sense
Explain the FDA trickle-down theory of regulation
Identify the main areas of security concern and the implications of threats in these areas
Explain how passwords are used to protect data and the importance of NOT sharing passwords