Industry websites, Praxis training materials and webinars and other reference materials related to computer system validation and software compliance.
References
Petition to Revoke 21 CFR Part 11
Date Published:
Fri, 09/17/2004September, 2004 citizen petition to the FDA from an Industry Coalition to revoke 21 CFR Part 11.
FOI Letter of Request
Example letter requesting FDA documents available due to Freedom of Information.
Little Book of Testing Volume II
Date Published:
Mon, 06/01/1998The Airlie Software Council's booklet of software testing basic concepts and implementation techniques.
SQA Response to Petition to Revoke 21 CFR Part 11
Date Published:
Fri, 10/22/2004October, 2004 Society of Quality Assurance response to the FDA regarding the petition to revoke 21 CFR Part 11.
Little Book of Testing Volume I
Date Published:
Mon, 06/01/1998The Airlie Software Council's booklet of software testing principles and best practices.
