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 does not state directly requirements for electronic records. This is included with Chapter 4 (also issued in January) which states in the principles:

EU Chapter 4

Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer's Quality Management System. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media. The main objective of the system of documentation utilized must be to establish, control, monitor and record all activities which directly or indirectly impact on all aspects of the quality of medicinal products.

This incorporates the use of electronic records into the quality management system. It continues in Record Types

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 is used to generate other records. For electronic records regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data

It is clear from Chapter 4 that electronic records (even in a hybrid state, paper and electronic data) must have the same integrity as paper based records. The regulated company must be able to show that the same good documentation practices are in place.

Discussion

The first step of ensuring compliance with either EU Chapter 4 or the FDA 21 CFR Part 11 is to identify what are your records or electronic raw data used first making GMP identified and documented.

The controls for electronic records should be assessed based on a documented risk assessment. The regulated company must determine the impact of the records to GMP. This can be used to support the documented risk assessment to support the level of controls required to ensure the integrity of the record.

An article on my Computer Systems Validation site provides an introduction to a Risk Based Approach to Electronic Records

ISPE GAMP Guide risk based approach to electronic records and signatures provides an excellent detailed guidance to the approach.