FDA Draft Guidance Spells Out New Part 11 Expectations

Draft Guidance Provides Direction on eRecords, eSignatures, eSystems, and More

Draft Guidance Provides Direction on eRecords, eSignatures, eSystems, and More

An important new draft guidance from the U.S. Food and Drug Administration (FDA) proposes enhanced direction on how to manage electronic records (erecords) and electronic signatures (esignatures) in clinical investigations, how to validate electronic systems (esystems), and how to implement audit trails for erecords.

The full draft guidance released on June 21, “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11—Questions and Answers; Draft Guidance for Industry; Availability,” can be viewed and commented on through Aug. 21.

The draft guidance, tied to 21 CFR Part 11 of the Code of Federal Regulations, is particularly valuable to sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties in that it provides more granular direction and detail than a typical FDA guidance.

In issuing the draft guidance, FDA says one of its goals is to “encourage and facilitate the use of erecords and systems to improve the quality and efficiency of clinical investigations.”

The proposed guidance is broad in scope and applies to several aspects of erecords and esignatures. Specific examples include:

  • Records required for clinical investigation of medical products that are maintained in electronic format (eformat) in place of paper, including all records necessary to FDA to reconstruct a study.
  • Records required for clinical investigations of medical products that are maintained in eformat and where the erecord is relied on to perform regulated activities.
  • Records for clinical investigations submitted to FDA in eformat under predicate rules, even if those records are not specifically identified in FDA regulations.
  • Esignatures required for clinical investigations intended to be the equivalent of handwritten signatures, initials, and other general signings.

In addition, the draft guidance addresses many 21 CFR Part 11 requirements for esystems used to create, modify, maintain, archive, retrieve, or transmit erecords in the following categories:

  • Esystems, including commercial-off-the-shelf (COTS) and customized esystems owned or managed by sponsors and other regulated entities.
  • Esystems outsourced by the sponsor or other regulated entities.
  • Esystems primarily used in the provision of medical care
  • Mobile technology and telecommunications systems.

The draft guidance is, in part, the FDA’s attempt to keep up with technology. In March 1997, the agency published a final rule to establish criteria that must be met when a record required by a predicate rule is created, modified, maintained, archived, retrieved, or transmitted in eformat in place of a paper record and when esignatures are used in place of handwritten signatures.

After much clamoring from regulated entities, the agency issued a Part 11 guidance in 2003. However, FDA admitted it was intended only to “provide a narrow and practical interpretation of Part 11 requirements.”

This time around, FDA hopes to clarify and expand on its risk-based expectations when it comes to validation, audit trails, and record archiving. It also reassures industry that, when finalized, the guidance will provide updated “recommendations for applying and implementing Part 11 requirement in the current environment of esystems used in clinical investigations.”

Author: Michael Causey