The short version: Cloud platforms can fully support 21 CFR Part 11 and EU Annex 11 requirements for electronic records and electronic signatures—but the cloud provider's infrastructure isn't a compliance program on its own. Achieving and maintaining Part 11 compliance in the cloud takes access controls, audit trails, qualified vendors, validated systems, and ongoing validation maintenance as software updates ship. This article explains what Part 11 requires, how it applies to cloud data and eSignatures, and how a continuous compliance approach keeps regulated cloud applications defensible over time.
If there is one thing you’ve heard over and over about the life sciences industry 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. For the full regulatory picture, see our overview of 21 CFR Part 11 compliance.
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.
Cloud reality check: Hosting a system in the cloud does not automatically make it Part 11 compliant. The regulation governs how you use the system—who can access it, how signatures are applied, whether audit trails are turned on and protected, and whether the system stays validated as it changes. The cloud is the venue; compliance is the practice.
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 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.
Cloud providers ensure the authenticity, integrity, and confidentiality of electronic records—but they are not regulated. Closing that gap is what compliance work is for.
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. That makes vendor qualification, security, and the protection of confidential records your responsibility—an area where life sciences cybersecurity practices reinforce Part 11’s access-control and integrity expectations.
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, applying risk-based methods such as Computer Software Assurance (CSA) to focus testing effort where patient safety and product quality risk is highest.
How cloud applications stay Part 11 compliant
- Qualify the vendor and platform. A defensible vendor audit confirms the cloud provider's controls before you rely on them.
- Assess against the regulation. A Part 11 and EU Annex 11 assessment maps system capabilities to requirements and surfaces gaps.
- Validate the system. Risk-based validation establishes that the application performs as intended for its regulated use.
- Maintain compliance continuously. Cloud applications change frequently; ongoing validation maintenance keeps every new release in a validated state instead of letting a backlog build.
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.
FAQ: Cloud Data and 21 CFR Part 11
Can data stored in the cloud be 21 CFR Part 11 compliant?
Yes. Cloud platforms can fully support Part 11 requirements for electronic records and electronic signatures. Compliance depends on how the system is configured and used—restricting access to authorized users, capturing complete signature metadata, enabling protected audit trails, and keeping the system validated—rather than on the fact that it is hosted in the cloud.
Does using a cloud provider make my system automatically compliant?
No. Cloud providers ensure the authenticity, integrity, and confidentiality of electronic records, but they are not regulated entities. Qualifying the vendor, assessing the system against Part 11 and EU Annex 11, validating it, and maintaining that validation over time remain the regulated company's responsibility.
What does 21 CFR Part 11 actually require?
At a high level, Part 11 requires systems restricted to authorized users; signed electronic records that capture the signer's name, date and time, and the purpose of the signature; the ability to detect unauthorized use of passwords and identification codes; and built-in audit trails. It also depends on data integrity, password security, and trained users who treat electronic signatures as legally binding.
How is EU Annex 11 related to 21 CFR Part 11?
EU Annex 11 is the European Union's equivalent regulation for computerized systems used in GxP activities. Companies operating globally typically need to satisfy both, which is why USDM's onboarding includes a combined Part 11 and EU Annex 11 assessment.
How do cloud applications stay compliant as they update?
Cloud applications release new versions frequently. A continuous compliance approach validates each relevant release as it ships and manages changes through change control, preventing the kind of validation-maintenance backlog that can put a system out of compliance.
Keep Your Cloud Compliant—Without Slowing Down
Moving to the cloud and staying 21 CFR Part 11 compliant are not mutually exclusive. With the right vendor qualification, validation, and ongoing maintenance, your regulated cloud applications can be both efficient and defensible.
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?
Services: USDM Cloud Assurance for regulated cloud applications