More and more life science organizations are looking to leverage cloud-based solutions that can be used anywhere, on any device, to support "good practice" quality guidelines and regulations (GxP). To carry out their digital transformation, customers in regulated industries trust Microsoft cloud services such as Microsoft 365, Azure, and Dynamics 365 to shorten their time to market, reduce costs, increase operational efficiency, and accelerate scientific innovation.
Each year Microsoft invests billions of dollars in designing, building, and operating innovative cloud services. But in this highly regulated industry, for you to even consider our services, we must earn and retain your trust. Microsoft cloud services are built around key tenets of security, privacy, transparency, and compliance; and we invest more each year to increase the confidence of our life sciences customers in Microsoft cloud services.
Microsoft aims to ensure the confidentiality, integrity, and availability of data, documents, and GxP applications for life science organizations. With each service, customer data benefits from multiple layers of security and governance technologies, operational practices, and compliance policies to enforce data privacy and integrity at specific levels.
Over time, we intend to make it easier for life sciences organizations to use Microsoft cloud services for their full portfolios of applications. We believe that this GxP guidance document is a key step toward that goal. Given the shared responsibilities of the cloud model, life science customers rely on the fact that Microsoft has implemented appropriate technical and procedural controls to manage and maintain the cloud environment in a state of control. Microsoft’s quality practices and secure development lifecycle encompass similar core elements as would be found in many life sciences customers’ internal Quality Management Systems and meet or exceed industry standards.
This guide should help demonstrate that you can develop and operate GxP applications on Microsoft Azure, Dynamics 365, and Microsoft 365 with confidence and without sacrificing compliance with GxP regulation. We look forward to working with you to help you achieve your digital transformation initiatives.
- Daniel Carchedi – Sr. Director Business Development & Strategy Life Sciences
GxP Guidelines for Microsoft 365, Dynamics, and Azure are attached below