GMP News - Computer Validation

15.08.12

FDA Warning Letters relating to Computerised Systems

Problems in connection with computerised systems have also been addressed in two actual FDA Warning Letters. Read more here.

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25.07.12

New Guide for Manufacturers of Stand Alone Software

On June 12, 2012 the Medical Products Agency (Swedish Authority) published an introduction to the so called MEDDEV 2.1/6 Guidelines. Click here to read more.

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25.04.12

Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 4

What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.

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18.04.12

Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 3

What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.

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11.04.12

Questions & Anwers on EU GMP Guideline Annex 11 "Computerised Systems" - chapters 1-2

What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.

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11.05.11

EMA's answers to FAQ on Computerised Systems

The EMA (European Medicines Agency) has just published answers to questions on computerised systems under "Q&A: Good Manufacturing Practices (GMP)". Read more here.

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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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