FDA OMB CDRH GMP Records Requirements

The document at the link provided was prepared by editing the converted PDF filesupporting FDA’s request to the Office of Management and Budget for continuation of record collection activities under the CGMP-Quality System Regulation for Medical Devices. It is primarily meant to be a convenience for persons who desire a listing of required records under the QS regulation. Some portions of the original file, such as time and money estimates of the record collection activities, have been deleted.

This aide was prepared by David Manalan.

SoftwareCPR Keywords: Part 11, Electronic Records, Electronic Signatures

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