This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. 21 CFR Part 11 Electronic Records and Electronic Signatures is a short rule with a lengthy and informative preamble. The attached training aid provides section of the rule side by side with relevant excerpts of the preamble with some...Read More
This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. The attached document is a SoftwareCPR training aid with commentary and explanation of 21 CFR Part 11 Electronic Records; Electronic Signatures by SoftwareCPR. Note the date of this document as this is an evolving area. erecordsesigscommentary09012000-346Read More
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Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.