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:. Perform ongoing risk assessment, get actionable insights, and simplify your compliance process when using Microsoft cloud services with Compliance Manager. Expand all. 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.
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 detail how Microsoft audit controls correspond to those requirements. 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.
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.
These define our responsibility for implementing and maintaining controls adequate to secure and monitor the system. Download the Azure FDA 21 qualification guide. Microsoft in-scope cloud services 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.
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