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FDA'S ELECTRONIC SIGNATURES/RECORDS PROPOSED RULE: CLOSED SYSTEM CONTROLS

This article was originally published in The Gray Sheet

Executive Summary

FDA'S ELECTRONIC SIGNATURES/RECORDS PROPOSED RULE: CLOSED SYSTEM CONTROLS section should be modified to require "'true copies of records in human readable form, comprising data from the master source' suitable for inspection," the Health Industry Manufacturers Association says in Nov. 29 comments to FDA. The agency's current proposal to require companies to "'generate true copies of records in both human readable and electronic form' is too restrictive and may not reflect the nature of some available electronic systems," HIMA contends.
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