Source: https://prisymid.com/blog/fda-21-cfr-part-11/
Timestamp: 2018-04-23 11:45:00
Document Index: 780345872

Matched Legal Cases: ['ART 11', 'ART 11', 'art 11', 'art 11', 'art 11', 'art 11']

FDA 21 CFR PART 11 | PRISYM ID
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FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper.
The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical products, and covers:
FDA 21 CFR Part 11 helps organizations reduce the cost of managing and documenting their entire labeling lifecycle, from routing and approval workflow, version control and comparison, to audit trails and reports.
By becoming FDA 21 CFR Part 11 compliant, manufacturers will benefit from:
Download our whitepaper: Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11