Food and Drug Administration CFR Title 21 Part 11

CFR Title 21 Part 11

FDA CFR Title 21 overview

The Law of Federal Regulations (CFR) contains the rules and regulations for CFR Title 21 Part 11 administrative departments and agencies of the US civil government. Each of the 50 titles of the CFR addresses a different regulated area.

FDA CFR Title 21 regulates food and medicines manufactured or consumed in the United States, under the governance 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 associations subject to FDA oversight. Any technology system that governs similar GxP processes as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) also requires confirmation of its adherence to GxP.

CFR Title 21 Part 11 sets conditions to insure that electronic records and autographs are secure, dependable, and original backups for paper records and handwritten autographs. It also offers guidelines to ameliorate the security of computer systems in FDA- regulated diligence. Subject companies must prove that their processes and products work as they’re designed to, and if these process and products change, they must revalidate that evidence. The stylish practices guidelines cover

Standard operating procedures and controls that support electronic records and  LMS autographs similar as data backup, security, and computer system confirmation.

Features that insure that the computer system is secure, contains inspection trails for data values, and ensures the integrity of electronic autographs.

Confirmation and attestation that supply substantiation that the system does what’s intended, and that druggies can descry when the system isn’t working as designed.

Microsoft and FDA CFR Title 21

CFR Title 21 Part 11

Microsoft enterprise pall services suffer regular independent third- party SOC 1 Type 2 and SOC 2 Type 2 checkups and are certified according to ISO/ IEC 27001 and ISO/ IEC 27018 norms.

Although these regular checkups and instruments don’t specifically concentrate on FDA nonsupervisory compliance, their purpose and objects are analogous in nature to those of CFR Title 21 Part 11, and serve to help insure the confidentiality, integrity, and vacuity of data stored in Microsoft cloud services. Our qualification approach is also grounded on assiduity stylish practices, including the International Society for Pharmaceutical Engineering (ISPE) GAMP series of Good Practices Attendants and the Pharmaceutical Inspection Cooperation Scheme (PIC/ S) Good Practices for Computerized Systems in Regulated GxP Surroundings.

Guests 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 give a detailed explanation of how Microsoft inspection controls correspond to the conditions of CFR Title 21 Part 11, guidance for enforcing an FDA qualification strategy, and a description of areas of participated responsibility.

Learn how to accelerate your FDA CFR Title 21 deployment Download the Azure FDA 21 qualification companion

Microsoft in- compass pall platforms & services

Although there’s no instrument for complying with CFR Title 21 Part 11, the following Microsoft enterprise pall services have experienced independent, third- party checkups, which may help guests in their compliance sweats. These services include

Azure Pall Services, Storage, Traffic Manager, Virtual Machines, and Virtual Network

Azure DevOps


Dynamics 365 and Dynamics 365U.S. Government

Office 365 and Office 365U.S. Government

Audits, reports, and instruments

The inspection reports for SOC 1 and SOC 2 Type 2, ISO/ IEC 27001 and ISO/ IEC 27018 norms attest to the effectiveness of the controls Microsoft has enforced and may help guests in their compliance with FDA CFR Title 21 Part 11.

Constantly asked questions

To whom does the standard apply?

FDA CFR Title 21 Part 11 applies to associations with products and services that deal in FDA- regulated aspects of the exploration, clinical study, conservation, manufacturing, and distribution of life wisdom products.

How do Microsoft enterprise pall services demonstrate compliance with FDA CFR Title 21 Part 11?

Using the formal checkups prepared by third parties for SOC 1 Type 2, SOC 2 Type 2, ISO/ IEC 27001, and ISO/ IEC 27018, Microsoft is suitable to show how applicable controls noted within these reports address the conditions.

Audited controls enforced by Microsoft help insure the confidentiality, integrity, and vacuity of data, and correspond to the applicable nonsupervisory conditions defined in Title 21 Part 11 that have been linked as the responsibility of Microsoft. The qualification guidelines for Azure and Office 365 detail how Microsoft inspection controls correspond to those conditions.

How can I get clones of the adjudicator’s reports?

The Service Trust Portal provides singly checked compliance reports. You can use the gate to request inspection reports so that your adjudicators can compare Microsoft’s pall services results with your own legal and nonsupervisory demand.

Can I use Microsoft’s compliance in the instrument process for my association?

Yes. The independent third- party compliance reports of the IEC/ ISO 27001, ISO/ IEC 27018, SOC 1, and SOC 2 norms attest to the effectiveness of Microsoft controls. Microsoft enterprise pall guests may use the audited controls described in these affiliated reports as part of their own CFR Title 21 Part 11 threat analysis and qualification sweats. Guests who make and emplace operations subject to FDA regulation are responsible for icing that their operations meet FDA conditions.


What are Microsoft’s liabilities for maintaining compliance with this standard?

Microsoft ensures that its enterprise pall services meet the terms defined within the governing Online Services Terms and applicable Service Position Agreements (SLAs). These terms define our responsibility for enforcing and maintaining controls acceptable to secure and cover the system.

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