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

GMP-News Nr. 346

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 theirinterpretation by FDA have the focus of discussion in recent years. Inparticular represented by an inspector, the requirements placed on theindustry in the form of "production of quality" have becomeincreasingly doubtful. For this reason FDA took the remarkable step inFebruary 2003 of withdrawing all the interpretative guidances to CFR Part11, but not 21 CFR Part 11 itself. At the same time, a new Draft"Guidance for Industry ... Scope and Applications" which was todescribe the further steps of FDA as regards the implementation of 21 CFR,Part 11 was published and presented for discussion. Following considerablediscussion 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 itwill also review Part 11 within the framework of the "CGMP initiativefor human and animal drugs and biologics" announced in 2002. Duringthis time the aspects described in the guidances withdrawn in February onvalidation, audit trail, record retention and record copying will not be thefocus of attention. FDA still clearly points out that Part 11 is in forceand that measures required in other predicate rules, e.g. in GMP Part210/211, still have to be fulfilled.

In the following are a few currentstatements from the new Guidance Document, as well as those which havechanged since the draft version:

  • The withdrawn Guidance Documents and theCPG (Compliance Policy Guide) are not being published again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  • In a footnote it is emphasized thatalthough the "Time Stamps" guidance has been withdrawn, itssubject matter is still quite relevant
  • All predicate rule requirements, alsothose concerning record and recordkeeping requirements will still bechecked by the authority
  • A list of Part 11 requirements which arestill valid is given, e.g. "limiting system access to authorizedindividuals", "use of operational system checks" etc.
  • The "narrow interpretation of thescope of Part 11" has hardly changed from the February draft.
  • Records which are not subject to apredicate rule but are archived in electronic form are not subject toPart 11
  • Validation activities required inpredicate rules must be carried out; but no further requirements are toresult from the Scope and Application Guidance.
  • Attention is expressly drawn to a riskassessment "...base your approach on a justified and documentedrisk assessment ..."
  • In the case of the following criteriaold systems (effective before 20.08.1997) are not taken intoconsideration
    • The system was operational beforethe effective date
    • The system met all applicablepredicate rule requirements before the effective date
    • The system curently meets allapplicable predicate rule requirements
    • You have the documented evidence andjustification 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 thePDF format
  • Archiving of the record: The electronicversion of records can be discarded if the contents and the meaning ofthe records are protected and stored elsewhere

Author: Dr. Andreas Mangel, CONCEPTHEIDELBERG

Youcan download the new Part 11 Guide here:




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