List of computer systems validation articles and information.
EU Annex 11 - Released 2011
EU Annex 11 Computerised Systems was issued in January 2011 to become effective on 30 June 2011. A series of posts reviewing the changes in the update.Validation - General Computer Systems Validation Articles
General articles relating to Computer Systems Validation including GAMP 5.Quality Risk Management
Posts relating to the management of a Science and Risk Based Approach to Computer Systems Validation.
CSV FDA Warning Letters
We can learn a lot from Warning Letters published by the Food and Drugs Administration (FDA). These posts all relate to inspection findings relating to Computer Systems Validation in the Pharmaceutical and Biotechnology industry. A link to the full warning letter is available with each post.