We recently released a detailed set of GxP qualification guidelines for our Azure customers. These guidelines give life sciences organizations, such as pharmaceutical and biotechnology companies, a comprehensive toolset for building solutions that meet GxP compliance regulations.
GxP is a general abbreviation for "good practice" quality guidelines and regulations. Technology systems that use GxP processes such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) require validation of adherence to GxP. Solutions are considered qualified when they can demonstrate the ability to fulfill GxP requirements. GxP regulations include pharmaceutical requirements, such as those outlined in the U.S. Food and Drug Administration CFR Title 21 Part 11, and EU GMP Annex 11.
Life sciences organizations are increasingly moving to the cloud to increase efficiency and reduce costs, but in order to do so they must be able to select a cloud service provider with processes and controls that help to assure the confidentiality, integrity, and availability of data stored in the cloud. Of equal importance are those processes and controls that must be implemented by life sciences customers to ensure that GxP systems are maintained in a secured and validated state.
Life sciences organizations building GxP solutions on Azure can take advantage of the cloud’s efficiencies while at the same time helping protect patient safety, product quality, and data integrity. Customers also benefit from Azure’s multiple layers of security and governance technologies, operational practices, and compliance policies to enforce data privacy and integrity at very specific levels.
The Azure GxP qualification guidelines give customers the tools they need to build on Azure’s security foundation by providing:
- The shared responsibilities between Microsoft and customers for meeting GxP requirements
- Documentation of the extensive controls implemented as part of Azure’s internal development of security and quality practices
- Visibility into crucial areas of internal Azure quality management, IT infrastructure qualification, and software development practices
- Recommendations for customer GxP compliance readiness
- Descriptions of GxP-relevant tools and features within Azure
We are partnering with our life sciences customers to make cloud-based GxP systems a safer, more efficient model for driving innovation and maintaining regulatory compliance.