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Warning Letter Citing Part 11 Signals FDA's Enforcement Position, Expert Says

June 7, 2005

A recent warning letter citing 21 CFR Part 11 validation and control requirements is a clear signal that the FDA will enforce the electronic records and signatures regulation even as the agency moves toward revising it, according to an industry expert.

In an April 11 warning letter addressed to Kenneth Rosenthal of Rosenthal Eye and Facial Plastic Surgery in Great Neck, N.Y., the FDA notes that the Rosenthal clinic uses an electronic medical record (EMR) system for patient clinical data in lieu of paper records. "Please note that Title 21, Code of Federal Regulations, Part 11, 'Electronic Records; Electronic Signatures,' outlines specific requirements that must be met for any system that is being used to maintain required records," the letter states.

The letter's rare mention of Part 11 caught the attention of compliance consultants and their clients. "In the [good manufacturing practices] area, we've seen much more attention paid to computer-related things in the medical device area than for drugs," said Lisa Olson, principal consultant at SEC Associates in Morrisville, N.C. "What's interesting about this [letter] is the specific focus on asking how the investigator has validated the system, how they have addressed being able to generate copies and [that the FDA is] expecting an audit trail."

"This letter indicates that these medical records are considered required regulatory records (part of the larger scope of 'case histories') and that data integrity should be demonstrated by accurate functioning of the system and the ability to tell if changes have been made to the records," Olson said. "This warning letter would seem to indicate that Part 11 is not a 'dead' issue after all (as some have hoped)."