FDA Warning Letter - Raw Data

Date: 23 February 2012
Link FDA 483 (New Window)
Observation4. Your firm has not established appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Your firm also fails to maintain a backup file of data entered into the computer or related system [21 CFR § 211.68(b)].


For

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Definition of Raw Data

Within EU Chapter 4 – Documentation there is a clear definition of Raw Data and the requirements to retain the raw data.

Records: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution. Records include the raw data which

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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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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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21 CFR Part 11 Warning Letters

From the review of the FDA Warning Letters I could not find any observations for pharmaceutical or biotechnology companies directly citing non compliance against 21 CFR Part 11.

21 CFR Part 11 - The next stepFrom the review of the published FDA Warning letters the observations relating to the security and electronic records have not been cited against 21 CFR part 11 however the agency selected

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