FDA Warning Letters - Risk Assessments

IntroductionAlthough to date I have not found any references within the FDA warning letters directly relating to computerised systems and risk assessments within the pharmaceutical / biotechnology industry it is interesting to review inspection findings where risk assessments have been detailed.

In this post there is a review of two FDA warning letters which reference the use of documented risk

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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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CSV FDA Warning Letters : Electronic Records

Date: 28 Jan 11
Link: FDA Warning Letter (New Window)
ObservationIn addition, we remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts. The current application was released into production on November 9, 2009 using an Interim Validation report (IVR) that is

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CSV FDA Warning Letters : Laboratory Systems Security

Date: 20 April 2010
Link: FDA Warning Letter (New Window)
ObservationThis is a follow up letter from an inspection in 2009 where the security of laboratory systems had been raised within the FDA 483.

6. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by

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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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