GMP News - Computer Validation


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.



FDA Plans New Part 11 Inspections

The topic of electronic records / electronic signatures is again on the FDA's current agenda. On 8 July 2010, the Agency announced that it would increasingly focus on the implementation of the 21 CFR Part 11 requirements during upcoming inspections. Read more here.



Webinar with FDA's John Murray on Software Validation in the Field of Medical Devices

Webinars are an efficient method for imparting information. A recent webinar with John Murray, FDA, is now available. Here you can read more.


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