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Data in the Cloud Can Be 21 CFR Part 11 Compliant

Data in the Cloud Can Be 21 CFR Part 11 Compliant

USDM Life Sciences specializes in helping life sciences companies achieve and maintain continuous compliance with their cloud solutions.

If there is one thing you’ve heard over and over about the life sciences industry this the past year or so, it’s that digital transformation and moving to the cloud are going full steam ahead.

USDM understands the importance of compliance with government regulations, including the U.S. Food and Drug Administration (FDA)’s 21 CFR Part 11 and the European Union’s equivalent, Annex 11.

What is 21 CFR Part 11?

When it comes to electronic records and eSignatures, the intent of the 21 CFR Part 11 regulation is to maintain accountability and traceability.

In part, it requires that:

  • Your systems be restricted to authorized users
  • Signed electronic records contain the name of the signer, the date and time of the signature, and the purpose of the signature
  • The system can detect unauthorized use of passwords and identification codes
  • Audit trails are built into the system

System management and storage of eSignatures also require data integrity and password security. Employees must be trained to comply with system controls and understand that their—and others’—electronic signatures are the legally binding equivalent of a handwritten signature.

Globally Compliant eSignatures

The partnership between DocuSign and USDM meets the quality and compliance demands of regulated businesses with a solution for globally compliant eSignatures and digital agreements. Plus, USDM’s Cloud Assurance™ ensures that end-to-end GxP compliance—from implementation through ongoing validation maintenance, including new software releases—for your cloud applications.

When you need to sign regulated documentation electronically, DocuSign can be used for Part 11 FDA-compliant signatures and HIPAA-compliant signatures and data storage. Cloud Assurance for DocuSign delivers fully validated eSignatures based on life sciences best practices, and system configurations can be modified via change control processes.

In one case study, USDM’s customer needed a fast solution for eSignature capabilities due to the COVID-19 remote working mandate. The customer was up and running with DocuSign in just seven days, obtained signatures 50% faster, and trusted USDM’s Cloud Assurance for maintaining continuous compliance and managing DocuSign updates.

21 CFR Part 11 and Cloud Data

IT cost savings is the primary reason companies are moving their data to the cloud, but maintaining compliance is cause for concern.

Cloud providers ensure the authenticity, integrity, and confidentiality of electronic records, but they are not regulated.

USDM specializes in solutions for regulated companies moving to the cloud. We adhere to best practices based on 20 years of life sciences compliance experience.

USDM’s Cloud Assurance onboarding and initial validation include a defensible annual vendor audit for the FDA, and a Part 11 and EU Annex 11 Assessment.

In another case study, a biotechnology customer fell out of compliance after accumulating a backlog of missed validation maintenance requirements. Their DocuSign usage across the company was expected to grow by 90% for the 21 CFR Part 11 team. Here’s how USDM helped.

USDM’s Cloud Assurance combines cost savings and risk reduction to manage your technology and compliance process from end-to-end so you can focus on other priorities. We can build processes and procedures that deliver results.

Contact our Cloud Compliance team to discuss your organization’s regulatory needs and tech stack. We understand the importance of business continuity and compliance, we meet all of your global regulatory requirements, and we are committed to delivering your Part 11 compliant solution quickly and correctly.

Additional 21 CFR Part 11 Learning Resources

Blog: How Do Life Sciences Companies Qualify Vendors and Software?


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