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GMP-News
8 September 2003
 

Final Version:
Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application
 

Requirements of 21 CFR Part 11 "Electronic Records / Electronic Signatures" and their interpretation by FDA have the focus of discussion in recent years. In particular represented by an inspector, the requirements placed on the industry in the form of "production of quality" have become increasingly doubtful. For this reason FDA took the remarkable step in February 2003 of withdrawing all the interpretative guidances to CFR Part 11, but not 21 CFR Part 11 itself. At the same time, a new Draft "Guidance for Industry ... Scope and Applications" which was to describe the further steps of FDA as regards the implementation of 21 CFR, Part 11 was published and presented for discussion. Following considerable discussion with the industry FDA has now published the final version of the "Guidance for Industry ... Scope and Application" on September 3.

In the introduction FDA announces that it will also review Part 11 within the framework of the "CGMP initiative for human and animal drugs and biologics" announced in 2002. During this time the aspects described in the guidances withdrawn in February on validation, audit trail, record retention and record copying will not be the focus of attention. FDA still clearly points out that Part 11 is in force and that measures required in other predicate rules, e.g. in GMP Part 210/211, still have to be fulfilled.

In the following are a few current statements from the new Guidance Document, as well as those which have changed since the draft version:

  • The withdrawn Guidance Documents and the CPG (Compliance Policy Guide) are not being published again
  • The "Scope and Applications" guidance describes the procedure of FDA during the revision of Part 11
  • In a footnote it is emphasized that although the "Time Stamps" guidance has been withdrawn, its subject matter is still quite relevant
  • All predicate rule requirements, also those concerning record and recordkeeping requirements will still be checked by the authority
  • A list of Part 11 requirements which are still valid is given, e.g. "limiting system access to authorized individuals", "use of operational system checks" etc.
  • The "narrow interpretation of the scope of Part 11" has hardly changed from the February draft.
  • Records which are not subject to a predicate rule but are archived in electronic form are not subject to Part 11
  • Validation activities required in predicate rules must be carried out; but no further requirements are to result from the Scope and Application Guidance.
  • Attention is expressly drawn to a risk assessment "...base your approach on a justified and documented risk assessment ..."
  • In the case of the following criteria old systems (effective before 20.08.1997) are not taken into consideration
    • The system was operational before the effective date
    • The system met all applicable predicate rule requirements before the effective date
    • The system curently meets all applicable predicate rule requirements
    • You have the documented evidence and justification that the system is fit for its intended use
  • As regards "copies of records" XML, SGML or other suitable formats are also named in addition to the PDF format
  • Archiving of the record: The electronic version of records can be discarded if the contents and the meaning of the records are protected and stored elsewhere

Author: Dr. Andreas Mangel, CONCEPT HEIDELBERG

You can download the new Part 11 Guide here:
http://www.fda.gov/cder/guidance/5667fnl.pdf

 

Of current interest: Part 11 in the LAB

From September 17-19, 2003 we are organizing the European Conference FDA/EU Requirements for Laboratory Computers and Records in Vienna. Make use of this opportunity to meet colleagues from throughout Europe at this conference and discuss with them the special consequences for laboratories.

 

Further events concerning Part 11: