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
SOP MANAGEMENT
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.
TRAINING MANAGEMENT
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.
CAPA MANAGEMENT
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.
CHANGE CONTROL MANAGEMENT
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.
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.
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
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