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.

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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).

Montrium has established a cloud governance framework that describes the processes, policies, roles and responsibilities that control how business divisions and IT teams cooperate to maintain a state of control over cloud based systems and processes. With proper planning, the management and governance of your cloud environment can be greatly simplified.
Our Professional Services team has performed numerous cloud vendor audits and understands the areas that present the biggest challenge and require special attention to detail.  Our standardized cloud vendor auditing process ensures efficiency and consistency across all audited cloud vendors.
Our Cloud Experts have the experience to help you to identify specific risks associated with hosting the GxP computerized system in a cloud environment and mitigation strategies.
Montrium’s Cloud experts can provide comprehensive training courses where they share their practical experience in developing risk based qualification strategies for cloud based applications and provide tools for performing a due diligence of cloud service providers.

Cloud Qualification

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.

Our design and configuration services focus on helping you develop a clear risk based strategy to prepare for the implementation and qualification of your cloud based virtual infrastructure (IaaS) while ensuring compliance with regulatory requirements.
Our Professional Services team have helped validate numerous different types of GxP applications hosted in the cloud, including: EDMS, EDC, eCTD and Safety systems.  We understand the various business processes managed by these applications and are able to assist you in your efforts to validate them against user and regulatory requirements.
As you implement cloud based GxP systems, it is imperative to ensure adequate SOPs are in place in order to maintain control and compliance with regulations, while also protecting your data. Montrium has prepared a standard set of SOPs which cover all the relevant IT processes with specific emphasis on the unique characteristics of managing regulated GxP applications in the cloud.
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