21 CFR Part 11 – Ensuring eRegulatory and eSource Compliance 2018-05-21T19:46:30+00:00

Flo’s Got Your Back | Ensuring FDA Title 21 CFR Part 11 Compliance

Introducing technology into clinical trial workflows is proven to accelerate research, save time, and reduce costs, however, it also can lead to new worries about complying with the FDA 21 CFR Part 11 requirements.

With Florence you can put these worries aside. We’ve worked with the FDA, sponsors, IRBs, and sites to design a solution that is not only the easiest-to-use eRegulatory platform, but also is fully compliant with all FDA Part 11 regulations, requirements, and recommendations.

Florence and FDA Title 21 CFR Part 11 Compliance

Florence 21 CFR Part 11 Resources

Part-11 Checklist
Complete FDA Guide to eReg
FDA Library of Guidance
FDA Logo Title 21 CFR Part 11 Compliance

Spend more time on research and less worrying about complying with regulations – Florence guarantees FDA Part 11 CFR 21 compliance.

How does Florence ensure Part 11 Compliance?

  • Easy-to-manage user access with unlimited custom roles and permissions
  • Custom SOPs that fit your workflow and needs
  • Document and binder audit trails available at any time
  • Compliant unique identifier for verified eSignatures
  • Our vendor SOPs available when needed
  • Training and regular updates on compliance, validation, and processes
  • Encrypted and secure document storage and transit, also complying with HIPPA regulations

FDA Title 21 CFR Part 11 Audit Trial
Learn more about Florence eBinders
Download FDA Guide to Part 11

What is Title 21 CFR Part 11?

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations establishing the US Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Most commonly referred to as Part 11, it establishes the criteria for trustworthy and reliable electronic records and electronic signatures.

Part 11 compliance is particularly important in clinical trials because it applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and research sites. To comply with the regulations companies involved in clinical trials must implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain.

Because of the complexity of rules and regulations surrounding Title 21 CFR Part 11 over the years, the FDA has released, in addition to formal regulations, informal guidance on how to best comply with the requirements.

Florence has deep experience and knowledge with compliance and works with each client to ensure FDA Part 11 compliance.

Additionally, Florence has developed an in-depth guide to eRegulatory and eSource compiled from over 150 questions and answers by the FDA.

Part 11 Implications

When dealing with Title 21 CFR Part 11 there are three primary areas a research site, sponsor, or CRO must think about. Florence works with all of our clients to map out each of these core areas and how they apply to their unique circumstances.

  • Features of Your System –Assurances for audit trail functionality, electronic signatures, security and data integrity, records retention and file formats are a few of the features that must be in place for an electronic system and/or process.
  • Standard Operating Procedures – Standard Operating Procedures (SOP’s) are required to be established and maintained to govern and describe exactly how things are done at that research site, sponsor, and/or CRO.
  • System Validation – Controls must be in place that allow research sites, sponsors and CROs to identify when the system doesn’t function as per its intended use. Here you should be utilizing your SOP’s and industry best practices to facilitate the validation process.

Additional Resources

Part-11 Checklist
FDA Guide to eReg
Part-11 Online Analysis

Questions about ensuring your team is up to speed on Title 21 CFR Part 11? Get in touch with us.

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