Guidances for Part 11 published by FDA on September 5, 2002

GMP News No. 235

18 September 2002



Guidances for Part 11 published by FDA on September 5, 2002



In Volume 67, Number 172 of the Federal Register FDA has announced the "Draft Guidance for Industry, Electronic Records; Electronic Signatures, Maintenance of Electronic Records". In the preamble to the requirements 21 CFR Part 11 "Electronic Records; Electronic Signatures" published on March 20, 1997 additional guidances for purposes of concretisation and interpretation were announced. The Draft Guidance now published supplements the only recently published guidances on Validation, Time Stamps and Glossary of Terms. The deadline for commentaries lasts until December 4 of this year.

The document comprises 27 pages. It deals with the maintenance and availability of electronic records during the retention period. Section 11.10 (c) of 21 CFR Part 11 stipulates that it is necessary to establish the following aspects: "procedures and controls for the protection of records to enable their accurate and ready retrieval throughout the records retention period You should update the procedures and controls as conditions warrant."

The procedures/instructions should, for instance, regulate the following items:

  • How are the electronic records stored?
  • What storage conditions exist and what safety measures are taken?

Section 5.3 of the new Draft Guidance reads that a representative number of electronic records must be read in at regular intervals in order to check whether these electronic records can still be read in. Furthermore, it reads that any "difficulties" observed during these checks while reading in the electronic records these should be migrated into the new electronic records.

The ambient conditions in which the electronic records are retained must also be permanently monitored. These are temperature, humidity as well as electromagnetic interference. Additional interesting comments can be found in the following as to what measures must be taken for the maintenance of electronic records. Special attention is drawn to the making of copies and the fact that all functionalities existing in an electronic record must continue to be available throughout the entire retention period.

Of particular interest are the two approaches to maintaining the availability of electronic records mentioned in Section 6. The first approach, the "Time capsule approach" assumes that the necessary hardware and software will also be retained throughout the retention period. These may not be modified in any way, i.e. for instance no updates may be performed on them. This approach - and the Guidance itself admits this - will tend to be the exception in view of today's technical progress. Applications can be seen above all where very short retention periods are involved.

The second approach, the "Electronic Record Migration Approach" will probably represent the most frequent case. Here the demands placed on the migration of data and metadata are very high. The present Guidance defines therefore in detail what measures are to be taken in case of migration. Here the migration process, e.g. also the Audit Trail Information must be transferred and the information of the Audit Trail must be supplemented by the information on the migration process itself. The problem of an electronic signature being connected with an electronic record is also dealt with. The migration process must take place with the involvement of a "trusted third party".

The European Compliance Academy (ECA) is organising in cooperation with Concept Heidelberg on December 2-3, 2002 in Barcelona the event GMP-/FDA-Compliant Raw Data Management and Archiving. Here the retention of raw data and metadata as well as data migration, data authenticity and data integrity will be discussed.

For the interpretation of Rule 21 CFR Part 11 and of the individual guidances we are also organizing in 2002 

Author: Oliver Schmidt, CONCEPT HEIDELBERG

You can download the commentated draft here:


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