Quality Connect Quality Management System

Enterprise Quality Management Software in the Cloud for the Life Sciences

In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays.

Montrium has designed its enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud.

Perfect for 

  • Pharmaceutical Companies
  • Contract Manufacturing Organizations
  • Medical Device Companies

Built to

  • Achieve compliance with GMP and GCP requirements
  • Introduce a proactive approach to quality
  • Increase efficiency with streamlined, automated workflows

Our Quality Connect Modules


Automate the entire lifecycle of your controlled documents

Montrium’s SOP Management module is designed to manage all controlled documents that form part of your quality system. Easy access, centralized distribution, intuitive workflows and strong integration with our Training Management module ensure that quality and compliance are at the heart of your operations.

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Facilitate the planning and completion of GxP training 

The Training Management module facilitates the planning and completion of SOP or regulatory training. An integrated training matrix coupled with intelligent form technology allows you to track and manage employee training more efficiently, ensuring that you meet all training requirements.

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Centralizing and empowering continuous improvement

The CAPA management module is an integrated deviation, incident and CAPA management solution which allows you to manage all of your quality events in one central location. The module comes pre-loaded with intuitive forms and workflows which adapt based on the type of quality event being managed.

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Empowering controlled, compliant change requests from start to finish  

The Change Control management module facilitates the request, creation, editing, approval, and tracking of change requests to enable end-to-end change control management. Monitor and manage changes as they happen to minimize risk, eliminate costly delays, free-up resources, and accelerate your time to market.  

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Realize the true benefits of an EQMS

Take your quality system to the next level

  • Reduced Regulatory Risk
  • Improved Traceability & Transparency
  • Automate Quality Processes
  • Reduction in redundant data
  • Collaboration and Accountability
  • Disseminate up-to-date policies and procedures
  • Out-of-the-Box Solutions
  • Accurate and Real-time information
  • Understand your overall quality health
  • Clear ROI

Increase quality and efficiency in the cloud

By centralizing your EQMS in the cloud, you can ensure that all internal and external process stakeholders can access and interact with your system anytime anywhere. The Quality Connect EQMS comes preconfigured and revalidated so you can quickly implement an intuitive and proactive quality system for today’s decentralized life sciences environments.

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Improve Quality. Increase Efficiency. Ensure Compliance.

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Why Our Customers Trust the Montrium QMS

Available in the Cloud

Our EQMS is available on our qualified Microsoft Azure environment significantly reducing time to implementation and TCO

Intelligent Workflows

Automated intelligent workflows drive quality processes and significantly improve collaboration and compliance

Structured Quality Data

Structured quality data allows you to drill into information and generate meaningful metrics and identify trends

Web Applications

Web-based applications allow users to access the system from any device anywhere

Iron Tight Compliance

Fully documented and tested in line with 21 CFR Part 11,  Annex 11 and GxPs

Digital Signatures

Digital Signatures

21 CFR Part 11 compliant digital signatures allow you to go fully electronic

Electronic Forms

Intelligent forms allow you to capture structured quality system data to drive processes and metrics

PDF Rendering

The automated PDF rendering of forms allows you to maintain long-term archives of quality records

Inspection Ready

Inspector view of quality system information allows you to provide access to quality events in a controlled environment

Ready to get started?

See how Montrium Connect could help your organization better manage quality events and documentation

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