"FDA withdraws Guidance for Industry 21 CFR Part 11, Electronic Records; Electronic Signatures on February 4, 2003"

February 25, 2003

Karl Mousley

 

On February 4, 2003, the FDA announced in the Federal Register: February 4, 2003 (Volume 68, Number 23) and published an announcement which states in part:

 

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled ``Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records.''

It should be clearly noted that the FDA did not withdraw 21 CFR Part 11. The regulation is still in place. The guidance however, which has the force of "strongly recommended", was withdrawn.

What happened? What does this mean?  In it's "new" draft guidance, the FDA states:

 

"Concerns have been raised that some interpretations of the Part 11 requirements would (1) unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule, (2) significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted, and (3) discourage innovation and technological advances without providing a significant public health benefit."

The FDA says the guidance was withdrawn "because we wanted to avoid loss of time spent by industry in an effort to review and comment on the draft guidance when that draft guidance may no longer be representative of FDA's approach under the new CGMP initiative." Furthermore the FDA says,

 

"As an outgrowth of its current good manufacturing practice (CGMP) initiative for human and animal drugs and biologics, FDA is embarking on a re-examination of Part 11 as it applies to all FDA regulated products. We may revise provisions of Part 11 as a result of that re-examination. This guidance explains that, while this re-examination of Part 11 is under way, we will narrowly interpret the scope of Part 11. It also explains that we intend to exercise enforcement discretion with respect to certain Part 11 requirements. We will not normally take regulatory action to enforce compliance with the validation, audit trail, record retention, and record copying requirements of Part 11 as explained in this guidance.

In addition, we intend to exercise enforcement discretion and will not normally take regulatory action to enforce Part 11 with regard to systems that were operational before August 20, 1997, the effective date of Part 11 (commonly known as existing or legacy systems) while we are re-examining Part 11."

So, while the FDA re-examines Part 11 and possibly revises the regulation, they will "exercise enforcement discretion" and "narrowly interpret the scope of Part 11". They will "not normally take regulatory action to enforce compliance" in a number of areas. Furthermore, the FDA apparently will not expect existing or legacy systems (i.e., systems implemented prior to August 20, 1997) be made 21 CFR Part 11 compliant.

Section III.B.2 of the draft guidance defines Part 11 Records, specifically identifying those records that it will continue to expect compliance to regulation 21 CFR Part 11.

In short, the following will fall under 21 CFR Part 11 regulations:

  • Records required by predicate rules that are maintained in electronic format in place of paper.
  • Records required by predicate rules that are maintained in electronic format in addition to paper if the electronic record is relied on to perform regulated activities. The FDA recommends the sponsor determine in advance and document in SOP, which records (electronic or paper) will be used for regulatory activity.
  • Records submitted to the FDA, under predicate rules, in electronic format.
  • Electronic signatures that are intended to be the equivalent of handwritten signatures or initials required by predicate rules.

Section III.C describes the FDA's approach to specific Part 11 requirements and its enforcement intentions.

  • Validation - The FDA intends to exercise enforcement discretion regarding specific Part 11 requirements for validation.
  • Audit Trail - The FDA intends to exercise enforcement discretion regarding specific Part 11 requirements for computer-generated, time-stamped, audit trail. The FDA further states that even when there are no predicate rule requirements to document changes, it suggests an audit trail be maintained.
  • Legacy Systems - The FDA intends to not enforce Part 11 compliance with these systems, it only states that they must comply with predicate rules and "be fit for their intended use."
  • Copies of Records - The FDA intends to exercise enforcement discretion regarding specific Part 11 requirements for generating copies of records. They recommend copies of records be produced in common portable formats, and using established automated conversion or export methods to make copies in a more common format (including PDF.)
  • Record Retention - The FDA intends to exercise enforcement discretion regarding specific Part 11 requirements for the protection of records throughout the records retention period.

Mousley Consulting, Inc. recommends those that work within the FDA predicate rule regulated environment to read the new draft guidance. Its is fairly concise and understandable.

 

Quick Definition:

A Predicate Rule - Any requirements set forth in the Federal Food, Drug, and Cosmetic Act, the public Health service Act, or any FDA regulation is referred to as predicate rules. Most predicate rules are contained in Title 21 of the Code of Federal Regulations (21 CFR.)

 

If you would like to be on our mailing list or to send me your comments, please email me at karl@mousleyconsulting.com. 

 

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