The Code of Federal Regulations (CFR) contains the rules and regulations for executive departments and agencies of the US federal government. Each of the 50 titles of the CFR addresses a different regulated area.
FDA CFR Title 21 regulates food and drugs manufactured or consumed in the United States, under the jurisdiction of the Food and Drug Administration (FDA), the Drug Enforcement Administration, and the Office of National Drug Control Policy. The regulations outlined in CFR Title 21 Part 11 set the ground rules for the technology systems that manage information used by organizations subject to FDA oversight. Any technology system that governs such GxP processes as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) also requires validation of its adherence to GxP.
CFR Title 21 Part 11 sets requirements to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent substitutes for paper records and handwritten signatures. It also offers guidelines to improve the security of computer systems in FDA-regulated industries. Subject companies must prove that their processes and products work as they are designed to, and if these change they must revalidate that proof. The best practices guidelines cover:
Microsoft enterprise cloud services undergo regular independent third-party SOC 1 Type 2 and SOC 2 Type 2 audits, and are certified according to ISO/IEC 27001 and ISO/IEC 27018 standards.
Although these regular audits and certifications do not specifically focus on FDA regulatory compliance, their purpose and objectives are similar in nature to those of CFR Title 21 Part 11, and serve to help ensure the confidentiality, integrity, and availability of data stored in Microsoft cloud services. Our qualification approach is also based on industry best practices, including the International Society for Pharmaceutical Engineering (ISPE) GAMP series of Good Practices Guides and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Practices for Computerized Systems in Regulated GxP Environments.
Customers can request access to the compliance reports, subject to nondisclosure agreement terms and conditions, through their Microsoft account representative, or through the Service Trust Portal. In addition, qualification guidelines for Microsoft Azure and Microsoft Office 365 provide a detailed explanation of how Microsoft audit controls correspond to the requirements of CFR Title 21 Part 11, guidance for implementing an FDA qualification strategy, and a description of areas of shared responsibility.
To whom does the standard apply?
FDA CFR Title 21 Part 11 applies to organizations with products and services that deal in FDA-regulated aspects of the research, clinical study, maintenance, manufacturing, and distribution of life science products.
Which Microsoft services are in scope for this standard?
Although there is no certification for complying with CFR Title 21 Part 11, the following Microsoft enterprise cloud services have undergone independent, third-party audits which may help customers in their compliance efforts. These services include:
How do Microsoft enterprise cloud services demonstrate compliance with FDA CFR Title 21 Part 11?
Using the formal audits prepared by third parties for SOC 1 Type 2, SOC 2 Type 2, ISO/IEC 27001, and ISO/IEC 27018, Microsoft is able to show how relevant controls noted within these reports address the requirements.
Audited controls implemented by Microsoft help ensure the confidentiality, integrity, and availability of data, and correspond to the applicable regulatory requirements defined in Title 21 Part 11 that have been identified as the responsibility of Microsoft. The qualification guidelines for Azure and Office 365 detail how Microsoft audit controls correspond to those requirements.
How can I get copies of the applicable audit reports?
You can access the independently audited reports on the Service Trust Portal so your auditors can confirm the compliance of Microsoft enterprise cloud services and compare those results with your own legal and regulatory requirements.
How can I get copies of the auditor’s reports?
The Service Trust Portal provides independently audited compliance reports. You can use the portal to request audit reports so that your auditors can compare Microsoft's cloud services results with your own legal and regulatory requirement.
Can I leverage Microsoft's compliance in the certification process for my organization?
Yes. The independent third-party compliance reports of the IEC/ISO 27001, ISO/IEC 27018, SOC 1, and SOC 2 standards attest to the effectiveness of Microsoft controls. Microsoft enterprise cloud customers may leverage the audited controls described in these related reports as part of their own CFR Title 21 Part 11 risk analysis and qualification efforts. Customers who build and deploy applications subject to FDA regulation are responsible for ensuring that their applications meet FDA requirements.
What are Microsoft's responsibilities for maintaining compliance with this standard?
Microsoft ensures that its enterprise cloud services meet the terms defined within the governing Online Services Terms and applicable Service Level Agreements (SLAs). These define our responsibility for implementing and maintaining controls adequate to secure and monitor the system.
The audit reports for SOC 1 and SOC 2 Type 2, ISO/IEC 27001, and ISO/IEC 27018 standards attest to the effectiveness of the controls Microsoft has implemented, and may help customers in their compliance with FDA CFR Title 21 Part 11.
Guidance for Industry Part 11: Electronic Records and Signatures