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Enforcement Policy: Electronic Records; Electronic Signatures – Compliance Policy Guide

FDA Update - Enforcement Policy: Electronic Records; Electronic Signatures - Compliance Policy Guide

Federal Register Announcement, July 21, 1999 - announced the availability of a new Compliance Policy Guide (CPG) section 160.850 entitled "Enforcement Policy: 21CFR Part 11; Electronic Records, Electronic Signatures."

This CPG is intended to represent the agency's current thinking on how to comply with the regulations for electronic records and electronic signatures. It also provides that agency decisions on whether or not to pursue regulatory actions will be based on a case-by-case evaluation.

The CPG goes on to state that the FDA will consider regulatory action with respect to Part 11 when the electronic records or electronic signatures are unacceptable substitutes for paper records or handwritten signatures, and therefore, requirements of the applicable regulations (e.g. CGMP and GLP regulations) are not met.

An example of a regulatory citation for a violations is as follows:

Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820.40, an failure to use authority checks to ensure that only authorized individuals can use the system and alter records, as required by 21 CFR 11.10(g). For example, engineering drawings for manufacturing equipment and devices are stored in AutoCAD form on a desktop computer. The storage device was not protected from unauthorized access and modification of the drawings.

For a copy of this regulation can be obtained via the FDA website, www.fda.gov/ora/compliance_ref/cpg/cpggenl/default.htm scroll down the CPG page to locate section 160.850. Or request a copy from mdi's office.

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