Professional Services
We’re focused on your success
Montrium’s competitive advantage rests in the quality of its service, responsiveness to customer needs, scope of international knowledge, and dedication to providing superior, timely, cost-effective and value-added solutions to customer problems in pharmaceutical development. Through a combination of our knowledge of GxP processes and our experience in system implementation, we are able to bring you enhanced value. Our team of experts build on a broad depth of industry expertise to implement solutions that meet the needs of today’s evolving and changing pharmaceutical landscape.
Our Professional Services include
Cloud Compliance
We have the experience and knowledge to help you smoothly move your GxP regulated applications and processes into the cloud.
Computer System Validation
We’re focused on reducing the overall burden of computer system validation while improving focus and quality throughout your organization.
Quality Assurance
Leverage our team of quality assurance and regulatory specialists to help you meet the regulatory requirements while improving quality oversight.
Technology Strategy
Work with our team of seasoned life science consultants to formulate and implement a coherent GxP IT strategy.
Why Choose Us?
We focus on helping life science companies select, audit, implement and validate computerized systems for GxP environments. Through the use of collaborative SharePoint technology we are able to automate and optimize project execution. With strong focus on knowledge transfer, our clients’ needs are captured at every step of the implementation process when following a holistic approach to project management. We take a lean, risk based end-to-end approach to reduce the time and complexity associated with the implementation of validated systems which in turn maximizes ROI.
INDUSTRY EXPERIENCE
Simply put, we understand your business. We’ve worked for years within industry to support the development and implementation of technology for the life sciences community.
QUALITY OF SERVICE
Over time, with the right mix of products and people, you begin to build a reputation for delivering the quality of service the industry demands. We are meticulous quality professionals where quality has always been a forethought, and never an afterthought.
FINGER ON THE PULSE
We pride ourselves on understanding the developments in the technology industry so that you don’t need too. Our technology recommendations are based on your specific needs, factoring in both the current technological landscape and the one that’s emerging.
We’ve also created some useful
Validation Accelerator Documentation packs
SharePoint Qualification Pack
The SharePoint Qualification pack includes a standard set of qualification documents that can be used to meet the requirements and procedural controls of 21 CFR Part 11 and Annex 11
DocuSign CoSign Qualification Pack
The CoSign Validation Pack includes a standard set of validation documents that can be used to speed up the implementation time and demonstrate compliance with the regulatory requirements
Azure Cloud Qualification Pack
The Microsoft Azure Cloud Qualification Pack includes a standard set of qualification documents which can be leveraged to greatly expedite the qualification process, providing a clear framework for cloud qualification.