Choose the right path to the cloud
If you are questioning whether the cloud can be validated for use in the context of GxP regulated applications, you’re not alone. There is still much uncertainty in the life sciences industry with regards to the use of cloud-based GxP regulated applications and cloud compliance due largely to a lack of regulatory guidance. The cloud brings many benefits, such as rapid scalability, high availability and resource pooling, but also carries several challenges with regards to data security, shared responsibilities and change management. Our team of cloud experts understand these challenges and have the experience to assist you in choosing the right path.
Our Cloud Compliance & Strategy Services
Montrium’s Professional Services team has consulted with leading cloud solution providers, as well as regulatory authority representatives to build a practical framework to assist life science companies in qualifying the cloud for GxP regulated applications and ensure regulatory requirements are met. As a result, we have developed a deep understanding of the unique benefits, risks, challenges and practical solutions to hosting GxP applications in the cloud.
Our team of Cloud Experts will guide you through each step of the process, including; vendor selection, auditing, implementation, validation and data/application migration. We will strive to share our knowledge and practical experience with you to allow you to develop long-term solutions and tools to qualify and maintain control over your GxP cloud-based applications.
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Cloud Compliance and Strategy
Developing a clear roadmap and strategy is the first step when deciding to move any GxP application into the cloud. Our experienced Cloud Experts have the practical knowledge to assist you in developing a clear strategy covering all cloud service models, including Infrastructure as a Service (IaaS), Platform as a Service (PaaS) and Software as a Service (SaaS).
Our Professional Services team have developed a comprehensive toolkit consisting of cloud vendor checklists, verification plans, risk assessments and mitigation strategies specifically tailored to help you qualify your cloud based GxP applications and enable you to achieve your compliance goals in a cost effective and timely manner.
What our customers say about us
We bought the Montrium Azure Qualification Accelerator Pack in order to qualify our Navision Infrastructure in the cloud. Though, the process of moving to the cloud can be quite time consuming, Montrium’s documents helped us greatly reduce the transfer time. I don’t think the process could have been made in a reasonable timespan without Montrium’s templates. In addition, the documentation gave us a good guideline on how to design the Infrastructure setup to the qualification requirements.