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

GMP News No. 235

18 September 2002



Guidancesfor Part 11 published by FDA on September 5, 2002



InVolume 67, Number 172 of the Federal Register FDA has announced the"Draft Guidance forIndustry,Electronic Records; Electronic Signatures, Maintenance of ElectronicRecords". In the preamble to the requirements 21 CFRPart11 "Electronic Records; Electronic Signatures" published on March20, 1997 additional guidances for purposes of concretisation andinterpretation were announced. The Draft Guidancenowpublished supplements the only recently published guidances onValidation, Time Stamps and Glossary of Terms. The deadline forcommentaries lasts until December 4 of this year.

Thedocument comprises 27 pages. Itdeals with the maintenance and availability of electronic records duringthe retention period. Section11.10 (c) of 21 CFR Part 11 stipulates that it is necessary to establishthe following aspects: "procedures and controls for the protectionof records to enable their accurate and ready retrievalthroughout the records retention period You should update the proceduresand controls as conditions warrant."

Theprocedures/instructions should, for instance, regulate the followingitems:

  • Howare the electronic records stored?
  • Whatstorage conditions exist and what safety measures are taken?

Section5.3 of the new Draft Guidance reads that a representative number ofelectronic records must be read in at regular intervals in order tocheck whether these electronic records can still be read in.Furthermore, it reads that any "difficulties" observed during thesechecks while reading in the electronic records these should be migratedinto the new electronic records.

Theambient conditions in which the electronic records are retained mustalso be permanently monitored. These are temperature, humidity as wellas electromagnetic interference. Additional interesting comments can befound in the following as to what measures must be taken for themaintenance of electronic records. Special attention is drawn to themaking of copies and the fact that all functionalities existing in anelectronic record must continue to be available throughout the entireretention period.

Ofparticular interest are the two approaches to maintaining theavailability of electronic records mentioned in Section 6. The firstapproach, the "Time capsule approach" assumes that the necessaryhardware and software will also be retained throughout the retentionperiod. These may not be modified in any way, i.e. for instance noupdates may be performed on them. This approach - and the Guidanceitself admits this - will tend to be the exception in view of today'stechnical progress. Applications can be seen above all where very shortretention periods are involved.

Thesecond approach, the "Electronic Record Migration Approach" willprobably represent the most frequent case. Here the demands placed onthe migration of data and metadata are very high. The present Guidancedefines therefore in detail what measures are to be taken in case ofmigration. Here the migration process, e.g. also the Audit TrailInformation must be transferred and the information of the Audit Trailmust be supplemented by the information on the migration process itself.The problem of an electronic signature being connected with anelectronic record is also dealt with. The migration process must takeplace with the involvement of a "trusted third party".

Author:Oliver Schmidt, CONCEPT HEIDELBERG

Youcan download the commentated draft here:



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