FDA Regulations – Title 21 CFR Part 11 – Pharmaceutical Compliance

We have the expertise to make your business compliant to FDA-CFR regulations


21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Title 21 CFR is related to regulations regarding Pharmaceuticals and Medical Devices and Part 11 being applicable to electronic records and electronic signatures.

Part 11 is a law which ensures that companies and organisations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. Part 11 essentially allows any paper records to be replaced by an electronic record and allows any handwritten signature to be replaced by an electronic one.

By introducing the 21 CFR Part 11 rule, the FDA has essentially enabled the FDA regulated industries to streamline business processes, reduce turnaround time and costs, all by establishing standard criteria for the use of electronic records and signatures. This rule helps businesses manage records and other content electronically, significantly decreasing the risk of human errors, reducing operational costs and minimizing time-to-market for pharmaceutical products.

TEKenable has experience of delivering validated systems for Clinical Trials and our staff additionally have experience of delivering system supporting:

  • Stability Trials;
  • Adverse Event (pre and post market) Reporting;
  • Regulatory License Submission and
  • Clinical Trials.

Our Approach

Electronic records must be maintained under described regulations to satisfy an FDA audit.

Under 21 CFR part 11, if a system is defined as “closed” then following points must be considered during software development;

  • System must be validated to ensure accuracy, reliability, consistent intended performance and ability to discern invalid or altered records
  • Record must be stored in such a way that they can be inspected, viewed or copied by FDA in both human readable and electronic form
  • Electronic records must be maintained for as long as the paper records that they replace
  • Secure, time stamped, along with time zone reference audit trails must independently record operator activities
  • Authorized individuals must have access to use, sign or alter existing record

If a system is defined as “open” (email records, internet-based apps, etc) then following items should be considered;

  • Document encryption maybe necessary to maintain confidentiality
  • Digital signature standards may be used to ensure record authenticity and integrity

As a Secure Software Development company, TEKenable fully understands Part 11 of CFR and is able to provide clients with the essential tools required to meet the standards of FDA regulations.

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