FDA Begins Roll-Out Of Electronic Records/Signatures Guidance
This article was originally published in The Silver Sheet
FDA ENFORCEMENT OF ELECTRONIC RECORDS & SIGNATURES requirements could increase in the coming months as guidance documents and technical solutions become more available. While the agency does not intend a full-scale crack down on violations of the "Part 11" rule, FDA will expect firms to be in compliance with the rule’s administrative and procedural requirements. The agency issues the first in a series of promised guidances on Part 11 implementation. At the same time, the trade groups PDA and ISPE jointly release the first of their "good practices" documents on e-records management.
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