The Cloud Brings a New Paradigm to Qualifying GxP Computerized Systems
Traditionally GxP computerized systems have been deployed on specific servers either directly or through the use of virtual machines. This underlying hardware was usually qualified, managed and specifically identified as being part of a specific instance of a GxP computerized system. With cloud computing this paradigm changes slightly. The Azure platform is composed of many hardware and software components which all fall under the same controls. Each time a new server or virtual machine is commissioned within the Microsoft cloud, it is done using the same process and standards. When considering public cloud based systems, it is important to view the whole public cloud as one system upon which we are able to install and run GxP computerized systems.
Qualification Guidelines and Documentation Packs for Windows Azure and Office 365 for Regulated Applications
Using the Windows Azure and Office 365 Cloud based platform for regulated applications requires conformity with 21 CFR Part 11 and Annex 11. Montrium has evaluated the controls that Microsoft has in place to meet the requirements and which controls need to be put in place by the regulated users of the Azure and Office 365 platforms. We have identified clear strategies for qualifying these environments for use with regulated applications in two qualification guidance documents which are available for download in our whitepapers section of this website.
In line with our guidance documents, Montrium can provide the relevant documentation templates and services to help you qualify your instance of Windows Azure or Office 365. These templates reference the relevant controls that are in place at Microsoft and also allow you to document and qualify the controls that you as a customer are responsible for. Contact us today if you would like to learn more about our templates or require assistance in qualifying your Azure or 365 environment.
If you are planning to use Windows Azure or Office 365 for regulated applications, contact us today to see how we can help you ensure your environments are compliant.