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Title FDA 21 CFR Part 11 compliance
URL https://www.compliancequest.com/21-cfr-part-11-compliance/
Category Business --> Business Services
Meta Keywords FDA 21 CFR Part 11 Compliance
Meta Description 21 CFR Part 11 is the FDA guideline that defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to that of the paper records.
Owner ComplianceQuest
An FDA compliance guideline, 21 CFR part 11 specifies the standards for evaluating the trustworthiness of electronic documents and electronic signatures.