Food and Drug Administration 21 CFR Part 11
The Food and Drug Administration Part 11 of Title 21 Code of Federal Regulations, Electronic Records; Electronic Signatures (21 CFR Part 11) applies to entities that maintain records or submit information to include records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act).
Since Part 11 became effective in 1997, the Food and Drug Administration has publicly emphasized their intent and commitment to overcome unnecessary restrictions on the use of electronic technology, significant costs of compliance and barriers to innovation and technology advances that stand in the way of public health benefit. The Part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems and others introduce potential barriers and restrictions especially for agencies working in constrained time, resource or emergent public health crisis.
Azure’s deep partnership with customers and partners in public sector health and life sciences industry resulted in the Qualification Guideline for Microsoft Azure. Working with the Qualification Guideline, entities are able to demonstrate Azure services and execution fulfills Part 11 requirements. To learn more about the customers and partners who have qualified their regulated applications running on Azure, download the Guide or the recorded webinar “Qualifying Microsoft Azure for Regulated Applications in the Life Sciences” from Montrium.
The Azure platform components which are within scope of this review include: Cloud Services (Web, Worker and VM roles), Azure Storage (Blobs, Queues, and Tables), Networking (Traffic Manager, Virtual Network), and Virtual Machines.