Validation Determination

In the article Computer System Impact / Risk Assessment from May 2010 I discussed the use of the Impact Assessment for a Computerised system to determine the validation requirements. This article continues with that theme to provide guidance on performing and documenting the assessment within a Validation Determination Statement (VDS) for a computerised system.

GxP AssessmentThe first stage of

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EU Annex 11 - Computer System Inventory

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines Annex 11 for computerised systems includes the requirement for the regulated company to maintain an up to date listing of relevant systems (GMP Computerised Systems) and their GMP functionality (inventory).

This is also a Japanese regulatory requirement and also an expectation of the FDA although not included within the

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Applying Computer System Security (GAMP)

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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EU Annex 11 - Electronic Signatures

Electronic Signatures
This is a continuation of a review of the update to EU Annex 11 and Chapter 4 (Documentation) that was issued in January 2011 to become effective on the 30 June 2011.

As stated in the previous article the EU Annex 11 update does not directly reference Electronic Records this is included in the update to EU Chapter 4 (Documentation).

The update to EU Annex 11 however does

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EU Annex 11 – Electronic Records

This is a continuation of a review of the update to EU Annex 11 and Chapter 4 (Documentation) that issued in January 2011 to become effective on the 30 June 2011.

Electronic Records have for so long only taken guidance from the FDA, however it has always been an expectation of the MHRA / EU that electronic records, including raw data must have the same integrity as paper records.

EU Annex 11

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EU Annex 11 – Supplier Audits

This is a continuation of a review of the impact of the update to EU Annex 11, issued in January 2011 to become effective on the 30 June 2011.

Supplier AuditsThe supplier audit process for software suppliers including IT systems, automation systems, etc has been around for quite some time within the guidance documents, but never directly referenced within cGMPs for pharmaceutical companies (e.g.

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EU Annex 11 – Risk Management

As stated in the earlier post EU Annex 11 has been updated and becomes effective on the 30 June 2011. This is part of a series of reviews detailing what has changed and the impact on Computer Systems Validation.

Risk Management now underpins the whole process of Computer Systems Validation. This has been a driving force since the introduction of GAMP4 and even more so through GAMP5.
In the

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EU Annex 11 (Update)

In January 2011 the European Commission (EudraLex) released Annex 11 Computerised Systems (revision 1) which comes in to effect on 30 June 2011.

This has been a long awaited release of the GMP Guideline for Computerised Systems which was first issued for comment in April 2008 for public consultation. The final release of Annex 11 has been reduced considerably to that put out for public

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