In Europe the EU GMP Guide Annex 11 "Computerised Systems" is the regulatory basis for GMP regarding IT systems in the pharmaceutical industry. The new version was issued on 3 January 2011 together with the EU GMP Guide Chapter 4 "Documentation". It will become effective on 30 June 2011. Read more.
The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way
Alongside validation, the (GMP-compliant) operation of computerised systems is also becoming an increasingly higher priority. A new GAMP Good Practice Guide gives comprehensive support on this matter. Read more here.
Recent Statement by FDA on Process Validation - 3-Batch Validation Obsolete?
In a recent questions-and-answers paper, the question if, according to cGMP, the manufacture of 3 validation batches is required before a new active pharmaceutical ingredient or medicinal product can be marketed is answered by the FDA in the negative. The reasons for the no can be found here.