Commitment to compliance in pharma and life sciences
Over a year has gone by since the beginning of the global pandemic, and it’s clear that the pharmaceutical industry and COVID-19 vaccines are at the center of everyone’s attention. Calls for quick and rigorous development of a COVID-19 vaccine have given way to the equally important demand for rapid distribution.
Because of this unprecedented situation, there’s been incredible pressure to support and manage a large data infrastructure to help administer and trace the distribution as well as how the vaccines work. Even long-standing cold chain technologies used to store vaccine doses are transforming under changing requirements for connectivity, access, and security compliance. The need for analytics, high-capacity storage, and increased computing power has expanded the need for data handling, analytics tools, and applications that only the cloud can support.
With that in mind, Microsoft continues its commitment to support the pharmaceutical industry. Our products and services are built with three important pillars in mind: security, privacy, and compliance.
GxP plays a central role in the journey to cloud. Today I am pleased to share that we will be releasing a series of blogs to help you operationalize GxP and Cloud. The goal is to guide and help with the specifics of compliance and governance, including how to work with customers and partners in the industry.
We’ll also provide materials that will help you enable digital transformation to the cloud, based on different use cases in the pharma industry, touching on areas such as research and development, manufacturing, and distribution.
We will continue to release guidelines for GxP and on that note, I am happy to announce the next version of D365 guideline is in final review and will be released very shortly. We will also address and provide updates on the partner space in future posts.
Achieving a compliant, cloud-based solution requires well-defined controls and safety measures by design. Getting into compliance demands a solid foundation and governance setup, which can be met by leveraging Microsoft’s rich resources for Installation guides, Operational documentation as well as our rich resources on how we build on trust. A lot of guides, examples as well as the principles for building a solid framework can be found on Microsoft Docs, these are the examples we help you operationalize. The responsibility of meeting these requirements falls on Microsoft, partners, and customers in both pharma and the life sciences in a shared responsibility matrix. Therefore, alongside our cloud products, Microsoft also provides resources for IT and quality assurance professionals to help them understand Microsoft’s compliance features and capabilities. Through our Compliance Whitepaper, you’ll learn how Microsoft helps you manage security, risk, and governance within current standards like ISO27001, SOC1/SOC2, HIPAA, and over 90 more and how those can be used in the journey toward compliance. We have resources to help partners in the pharmaceutical industry navigate compliance GxP compliance with our GxP Guidelines on Azure , GxP Guidelines on M365, as well as the first version of the GxP Guideline for D365, all co-produced by our partner Montrium.
Using a zero-trust architectural principle with secure, comprehensive toolsets from Microsoft Azure, Microsoft 365, and Dynamics 365, you can adhere to all industry best practices while maintaining any security measures and compliance requirements you face.
Always keep in mind that compliance starts with governance, control, and trust by design.
