How to Comply with The FDA’s 21 CFR Part 11

Regulatory Requirements for FDA Compliance

If you work in a field that is regulated by the FDA, you will be obliged to prove the validity of all digital data under FDA 21 CFR Part 11. In many circumstances, an audit will be necessary to verify this. Your company’s compliance with FDA 21 CFR Part 11 is based on its ability to demonstrate processes and controls that ensure:

  • Authenticity
  • Integrity
  • Confidentiality
  • Irrefutability

Table of FDA 21 Part 11 Compliance

To comply with FDA CFR Part 11, you must ensure that the checks in your software or operational systems can be traced, confirmed, and audited if necessary. This means that if your software doesn’t track every step of the process automatically, you’ll need to create a workflow or operational system check that captures and gives the necessary data.

  • Export PDF documents
  • Store your data on a cloud that is considered closed
  • Maintain audit trails
  • Keep an all-in-one solution, which means the workflow is always in sync
  • Keep track of physical locations and user responsibilities in a hierarchy
  • Add a date, time, and unique user data to electronic signatures

eSignatures

  • They must provide a printed name, date, and time, as well as the signature’s meaning
  • Electronic Signatures must be permanently linked to the records they are associated with
  • Individuals signing must provide identification and ensure that their signature is distinct
  • Follow any design specifications for biometric (fingerprints) or non-biometric collection methods
  • Follow the rules for passwords and devices that generate passcodes
  • Finally, before using electronic signatures, you must notify the FDA

How Do You Notify the FDA That You’ll Be Using Electronic Signatures?

Begin by mailing a Letter of Non-Repudiation Agreement to the FDA. Make sure it’s on letterhead that matches your company’s and signed with a handwritten signature. You should have no trouble obtaining approval as long as your eSignatures meet all the requirements listed above.

Part 11 of the FDA’s 21 CFR Summarized

The Food and Drug Administration (FDA) is in charge of ensuring the safety of American residents’ food, pharmaceutical items, medical supplies, veterinary medications, cosmetics, and radiation-emitting products.

What is the Purpose of FDA CFR Part 11?

The goal is to ensure that you can trust your electronic records and eSignatures.

Exemptions from the FDA’s 21 CFR Part 11

If you have a paper record and prefer to scan and submit it digitally, you may be exempt from FDA 21 CFR Part 11. Alternatively, if you collect your data using a software system that generates printouts that are needed for submissions. Finally, you may not be subject to Part 11 if you employ legacy software that was implemented before August 20, 1997.

Conclusion

If you’re ready to bring your company into the golden age of administration automation then you must standardize your system according to the FDA’s part 11. (provided you work in a field governed by the FDA of course)

About BIS Safety Software:

BIS Safety Software was founded in 2006 and offers learning & compliance software for EH&S professionals, including a learning management system, training matrix, and much more. BIS also offers digital forms for site audits, incident reports, and many other form-based tasks.

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