Title 21 CFR, Part 11 | Food and Drug Administration (FDA) | Guidelines & Documents for Compliance

Title 21 CFR, Part 11 states the following:
“The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”

-source: www.fda.gov

Compliance with Title 21 CFR, Part 11, contains the following specific language, for which operational, business specific, and information security policies and procedures would be extremely helpful and beneficial:

  • Limiting system access to authorized individuals.
  • Use of various “checks”, such as operational, authority, and device checks.
  • Establishment of written policies
  • Appropriate controls over system documentation
  • For “Validation, undertaking a “justified and documented” risk assessment procedures as necessary.
  • For “Audit Trails”, have them in place, or other “physical, logical, or procedural measures in place…”
  • For “Legacy systems”, have “documented evidence and justification” that the system is indeed fit for use as intended.
  • For “Copies of Records”, have "established...conversion...methods" in place.
  • For “Records Retention”, the "protection of records to enable their accurate and ready retrieval...".

Security Policies for Title 21 CFR, Part 11 | Download Today 

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