Date Published:
Wed, 06/25/2008
References
ValGenesis Product Review
Date Published:
Tue, 01/02/2007In November, 2007, ValGenesis, the maker of the ValGenesis Validation Management and Tracking System, provided Validationcenter.com with an online demonstration of the latest version of their application. This review summarizes some of the features of the system with utility for Computer System Validation.
FDA Globalization Act of 2009
Date Published:
Wed, 01/28/2009The FDA Globalization Act of 2009 has been submitted to Congress by Representative John Dingell (D-MI) to increase the FDA's scope of funding and authority.
See sections 201-212 for new provisions for pharmaceuticals and medical devices. It's worth noting that this bill proposes a risk-based approach to inspection frequency (Sec. 202) and use of Quality Risk Management Plans (Sec. 505).
Computer System Validation Boot Camp Issue Log
Date Published:
Sun, 02/24/2008Students in the Praxis Computer Systems Validation Boot Camp use this Issue Log exercise during the course.
FDA Software Recalls 2002
Date Published:
Tue, 12/31/2002The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2002 and focuses on computer or software related information.
FDA Software Recalls 2003
Date Published:
Wed, 12/31/2003The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2003 and focuses on computer or software related information.
FDA Software Recalls 2004
Date Published:
Fri, 12/31/2004The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2004 and focuses on computer or software related information.
FDA Software Recalls 2005
Date Published:
Sat, 12/31/2005The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2005 and focuses on computer or software related information.
FDA Software Recalls 2006
Date Published:
Sun, 12/31/2006The data in this report is aggregated and summarized from the FDA Enforcement Reports for January-December 2006 and focuses on computer or software related information.
References
Industry websites, Praxis training materials and webinars and other reference materials related to computer system validation and software compliance.
