GMP News - Computer Validation

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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14.07.10

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.

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19.05.10

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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