Computers and Technology
Computers and Technology, 04.12.2019 06:31, Jasten

The fda's regulations related to electronic records and electronic signatures (21 cfr part 11) are intended to: allow the use of electronic documents and signatures in the regulatory process for drugs and devices. provide specific standards for the informed consent process. require use of electronic records for all drug research. prohibit the use of paper printouts of electronic records.

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