Electronic records final rule exemption of existing systems inappropriate, FDA says.
This article was originally published in The Tan Sheet
Executive Summary
ELECTRONIC RECORDS FINAL RULE's EXEMPTION OF EXISTING SYSTEMS INAPPROPRIATE, FDA states in a March 20 Federal Register notice announcing the agency's final rule on electronic records and signatures. The final rule represents "minimal standards," therefore, FDA says, a "general exemption for existing systems that do not meet these provisions would be inappropriate and is not in the public interest because such systems are likely to generate electronic records and electronic signatures that are unreliable, untrustworthy and not compatible with FDA's responsibility to promote and protect public health."
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