29. What is Title 21 CFR Part 11 and why are documented policies and procedures an important component of Part 11 compliance and do you offer such material?

Title 21 CFR, Part 11 is officially a portion within the United States Code of Federal Regulations (CFR) that relates to criteria pertaining to the Food and Drug Administration’s (FDA) guidelines applicable to electronic records, specifically, 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

Security Policies are a Must for Title 21 CFR, Part 11 Compliance

For scope purposes, Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted as noted by records requirements (i.e., predicate rules) set forth in specific regulations. In simpler terms, Part 11 requires FDA regulated industries to implement a broad set of operational, business specific, and information security controls (i.e., policies, procedures, and processes) for ensuring the confidentiality, integrity, and availability (CIA) of electronic records and all other applicable data. And though interpretation of Part 11 has come under scrutiny since its inception, it’s worth noting that explicit language has been published regarding various mandates, such as the following:

  • 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...".

Download Policies and Procedures for Title 21 CFR, Part 11 Compliance

As you can clearly see, Title 21 CFR, Part 11 does require a number of operational, business specific and information security policies and procedures to be in place for compliance, and the FLANK21 set of documents from FLANK is a great place to start. With hundreds of various templates available, organizations will find a number of essential documents for helping comply with Title 21 CFR, Part 11 policy and procedure requirements.  Compliance is important - regardless of what law or industry specific requirement it is - and it all starts with policies and procedures from FLANK.