Date Published:
Wed, 06/25/2008
Free
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.
CuraeLase, 12/11 FREE
Date Published:
Fri, 12/09/2011Warning Letter observation regarding the lack of documented specifications and testing for medical device software
Galloway Technologies, 8/11 FREE
Date Published:
Thu, 08/25/2011Warning Letter citations including lack of system validation, risk analysis, and documentation.
Beckman Coultier, 11/11 FREE
Date Published:
Tue, 11/01/2011Warning Letter citing multiple examples of CAPA process failure for software used in medical devices. Includes failure to investigate software vendor processes.
EMA Reflection Paper on Risk Based Quality Management in Clinical Trials (2011 draft)
Date Published:
Thu, 08/04/2011The European Medicines Agency (EMA) publishes “Reflection Papers” to communicate expectations to industry.
This draft guidance was released for public comment in August, 2011. The comment period extends through February 15, 2012.
FDA 483 Summary for Fiscal Year 2010 FREE
Date Published:
Wed, 05/25/2011This document summarizes and categorizes the number of US FDA 483s issued during fiscal year 2010 via the FDA's TURBO EIR system
Computer specific related regulations cited include 21 CFR 820.70(i), 21 CFR 820.30(g), 21 CFR 820.181(a), 21 CFR 211.68(a) and (b), 21 CFR 123.9(f), and 21 CFR 1271.160(d).
Japan Q&A on GMP Guideline on Managment of Computerized Systems
Date Published:
Thu, 10/21/2010In August 2011, an independent Computer System Validation study group produced this English translation of the Q&A document that accompanies the 2010 Japanese Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drags and Quasi-drugs.
Japan GMP Guideline on Managment of Computerized Systems
Date Published:
Thu, 10/21/2010In August 2011, an independent Computer System Validation study group produced this English translation of the 2010 Japanese Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs.
Beckman Coulter, 8/11 FREE
Date Published:
Tue, 08/09/2011Warning Letter describing failure to perform system integration testing and code review prior to software change.
