Leading Compliance Specialists Enable Life Sciences organizations to host Regulated Applications in the Cloud
Montreal, CA. 06/04/16 – Montrium, a leading regulated Enterprise Content Management software provider, and experienced technology consulting group, today announced the release and availability of a Cloud Qualification Document Pack for Microsoft’s Azure IaaS offering, enabling Life Sciences organizations to implement and maintain compliant cloud-based solutions. Montrium is one of the only established technology vendors currently offering cloud qualification documentation templates and cloud compliance services to the Life Sciences industry.
Montrium has developed a close working relationship with the Microsoft Healthcare & Life Sciences over several years and have been instrumental in developing an appropriate framework and guideline for qualifying Microsoft Azure for regulated applications.
“The qualification pack that we’ve created enables life sciences organizations to simplify regulatory compliance by operating from a framework for cloud qualification which speeds up qualification timelines and minimizes the overall qualification cost”, said Michael Zwetkow, Vice-President of Professional Services & Alliances at Montrium. “Our goal with the Cloud Qualification Pack was to provide a standard set of documentation that supports the entire qualification process and addresses the unique characteristics for demonstrating compliance with cloud based solutions.”
Through Montrium’s involvement in previous qualification reviews of Microsoft’s Azure Platforms, as well as the implementation of their own Azure environment for Montrium’s software solutions, they have been able to gain important access to Microsoft’s audit reports, system documentation and certifications to build a consistent and tested framework for approaching cloud qualification. This framework has culminated in the development the Microsoft Azure Cloud Qualification Pack.
“As we continue to see the proliferation of the cloud, life science organizations are challenged with the need to mitigate risk and manage compliance in the cloud. At Microsoft, we are committed to addressing these challenges through the development of industry-leading security measures and privacy policies, and have participated in independently verified compliance programs, audits and assessments.” said Egbert Schroeer, Worldwide Managing Director, Process Manufacturing & Resources at Microsoft. “Montrium is truly a cloud compliance leader, and they have become a trusted advisor in the Life Sciences industry when it comes to cloud qualification and cloud compliance strategy. Montrium’s consultative expertise will facilitate the interpretation of the requirements. The cloud qualification offering released today is providing Pharma & Life Sciences organizations with a clear path to cloud compliance.”
The documentation pack consists of several key qualification documents, including test scripts, which leverage Montrium’s knowledge and experience in cloud architecture, deployment and qualification. The content of each document is aligned with industry standards, as defined within ISPE’s GAMP IT Compliance and Qualification guidelines. The full list of included documents is as follows:
- Qualification Plan
- Risk Assessment
- Requirements Specification
- System Description
- Configuration Specification
- IQ Protocol + Test Scripts
- OQ Protocol + Test Scripts
- Traceability Matrix
- Qualification Summary Report
In addition to the release of the Microsoft Azure Cloud Qualification Pack, Montrium’s expert team are also actively working with Life Science organizations to help transition their regulated content to the cloud, both through their electronic content management platform Montrium Connect, as well as their Cloud Compliance Strategy and Qualification Services.
Montrium is a global leader in cloud-based document & quality management solutions and GxP consulting services for the Life Sciences. Operating in the Life Sciences for over 10 years, Montrium has been successfully helping organizations implement and maintain technology to improve their business processes and increase compliance. For more information on the products and services Montrium provides, please visit their website: www.montrium.com
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