Computer Systems Validation

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Monday, 11 April 2011

Applying Computer System Security (GAMP)

Posted on 08:06 by Unknown
It is a regulatory requirement that access to computerised systems is limited to authorised users. This not only limited to systems that contain electronic records but all systems that are used to fulfil regulated activities.

This post focuses on the FDA and MHRA / EU requirements regulatory requirements for security management of computerised systems within the pharmaceutical and biotech
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Posted in EU Annex 11, GAMP 5 | No comments
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