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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Deleting Electronic Data

Hybrid Systems (Deleting Electronic Data)
In Hybrid systems the computerised system is used to generate a record which is printed and hand signatures applied. The decision for the regulated company is whether the electronic record (or raw data) should be kept or deleted from the system.

In the FDA Guidance “Part 11, Electronic Records; Electronic Signatures — Scope and Application” under

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CSV Periodic Review

Regulatory requirement
Both the FDA and EU GMP’s detail the requirement for demonstrating that a computer system remains in a validated state throughout its operating history.

FDA 21 CFR 211.68(b) States:
“Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based

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Spreadsheet Validation

Spreadsheets have become commonly used within a wide range of applications within the pharmaceutical and biotechnology industries. These range from the management of documentation lists through to complex algorithms used to support batch release.

This post provides a description of a risk based approach to the validation of spreadsheets. As with all posts comments are welcome.
The approach to

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