GMP News - Computer Validation

19.01.11

New EU GMP Guide Annex 11 "Computerised Systems"

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.

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15.09.10

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.

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