Our quality management software features

 See what’s inside Montrium's Quality Connect, the industry's leading cloud-based quality management software built to optimize quality and compliance processes across your organization once and for all. From improved traceability to a noticeable reduction in redundant data, our quality management system is driven by Montrium's mission to simplify your day-to-day with an enterprise-grade QMS software that's a breeze to use.

Document management

Montrium's document control software keeps things real-time and friction-free so you're in constant control of where documents are at. Our collaborative quality management software features empower quality teams to maximize quality processes so you can keep your eye on what really matters: reaching your key performance indicators.

Document Template Center & File Plan

Our quality management solution helps teams accelerate and streamline the process of creating and filing documents with a dedicated template center. 

Real-time Collaborative Authoring

Remove friction in the document writing and review process by taking advantage of real-time, collaborative authoring in our quality management software.

Configurable Review & Approval Workflows

Maximize efficiency and improve document control as your automate the review, approval  and version control of quality documentation by using intelligent workflows in Montrium's QMS software.

Configurable Document Types & Subtypes

Don't get held back by the types of quality documentation you're looking to manage. Set up configurable document types and sub-types directly in the quality management system.

Native Integration with M365 & Office

Seamlessly connect your quality environment to other critical business processes with native Microsoft 365 and Office integration. 

Records Center for Archiving

Easily keep track of all quality documents with a digital records center designed to make archiving a breeze. 

21 CFR Part 11 & Annex 11 Digital Signatures

Sign documents in the blink of an eye with digital signatures that are fully compliant with 21 CFR Part 11 and Annex 11. 

Built-in PDF Conversion Engine

Speed up file conversion and avoid third-party tools by leveraging a PDF conversion engine baked into Montrium's quality management software.

Google-like Search & Retrieval Tools

Make finding and retrieving documents as simple as looking up a nearby restaurant with Google-like search tools. 

Training management

The training management features in our robust QMS software are built to ensure that employee training processes are optimized for operational efficiency and of course, simplified.

Training Task Automation

Do away with time-consuming administrative work thanks to automated training scheduling and task assignment that takes the headache out of managing employee training.

Centralized Role-based Training Matrix

Quickly define who needs to be trained on what with an integrated, role-based training matrix as part of our quality management system for scaling teams.

Training Gaps Identification & Remediation

Instantly identify and remediate training gaps for individuals, departments, or courses using advanced reporting. A quality management software feature designed to do the heavy lifting for you.

Audit Friendly Reporting

Audit management is a pillar of our quality management software. Easily and efficiently export training records to ensure that your next audit goes off without a hitch. 

Online Quizzes

Verify any employee’s understanding of the training materials through documented online quizzes built into our quality management software.

Works with LMS systems

Bridge the divide between quality and learning management by investing in a quality management software that works with your existing LMS systems. 

Role Restriction Across your Organization

Managing training across your organization no longer needs to feel like a chore. Control access only to what specific teams need, when they need it.

Centralized e-Learning Content

Keep all of your e-learning materials in one place thanks to centralized content management built to optimize your quality management processes.

Quality events & CAPA management

Montrium's quality management software features are a game-changing addition to any quality team looking to simplify complex processes in quality event reporting and CAPA management.

Intelligent Event Capture

Save time with intuitive forms that adapt automatically based on the type of quality event being reported. 

Support for SCARs

Improve supplier quality management with built in supplier corrective action requests with digital forms and structured workflows. 

Track any quality event

Centralize and control all your quality events, issues and incidents in one place with full configurability. 

Streamlined workflows & processes

Our integrated workflow engine routes the incident to the appropriate individuals for investigation and closure. Drive continuous improvement while you track defects and issues that arise.

Flexible reporting & KPIs

Real-time key performance indicators (KPIs) and flexible reporting features give you crystal clear insight into your quality system. 

Action creation & tracking

Create, allocate, and track actions with clear due dates to ensure that CAPAs are executed effectively and efficiently. 

Task & reminder automation

Cut down your to-do list with automated tasking, completion monitoring, and reminder notifications. 

Connect incidents & CAPAs together

Group and connect common incidents together, initiate corrective action easily when it’s necessary. 

Root Cause Analysis support

Perform root cause analysis directly in the CAPA form and associate actions to each of the causes. 

Change control management features

Automated workflows, configurable reporting views and time-stamped audit trails are just a few of Quality Connect's standout change management features, fit for teams driven by continuous improvement and a simpler way of doing things.

Centralize change control management

Simplify your supply chain and streamline change management across your entire organization with centralized change control planning.

Track change causation and rationale

Effectively document your change management process, available and auditable always so you remain in regulatory compliance. 

Automated workflows & notifications

Clear up your calendar thanks to quality management software that executes automated workflows and sends notifications for you. 

Configurable reporting views

See your change control progress in the way that makes the most sense for your environment with configurable reporting views. 

Extend across use cases

Built as a flexible and powerful change control tool, you can leverage it for major process change, new equipment, implementing software, risk management, supplier quality management, improving production processes and much more. 

Time-stamped audit trails

Effortlessly create a robust and time-stamped audit trail thanks to intelligent change form capturing that meet your compliance requirements.

Administration, security & compliance

Most quality leaders talk about improvements to efficiency and cost as they look to build a business case for purchasing quality management software. However, we think it's just as important to focus on the benefits your team will realise in improved security and compliance. Built with your business in mind, our quality management software brings together one of the most easy to use platforms you'll lay your hands on, always built on a foundation of quality and compliance.

Aligned with GxP requirements

Effortlessly achieve GxP compliance with a system that’s purpose-built to align with and uphold the requirements. 

Compliance with GDPR from the ground up

Features and functionalities designed to help you achieve end-to-end GDPR compliance with ease. 

Robust security & access management

Robust security and access management lets you share what needs to be shared and protect what needs to be protected. 

21 CFR Part 11 & Annex 11 compliant

Rest easy knowing that your digital signatures are fully compliant with 21 CFR Part 11 and Annex 11. 

SSO & active directory integration

Avoid frustrations with logins, security, and network administration thanks to SSO and active directory integration. 

QMS aligned with ISO standards

Our QMS has been thoughtfully aligned to the ISO standards for quality management systems. 

Built on industry standards & best practices

Stay consistently aligned with industry standards and best practices thanks to a quality management software that’s built on them. We focus on continuous improvement in our quality management software features by making changes to our product as the industry demands them.

Custom integrations available with other systems

Streamline and centralize all of your processes with custom integrations to make system-to-system communication easier. 

Advanced Data Export & Content Portability

Take your data wherever you need it. Built in export functionality allows you to port content and data to be used across your organization. 

Ready to upgrade your quality process?

See the Montrium QMS in action in a live demo.

Built-in security & compliance

We take the responsibility of helping you manage clinical trial data seriously. That’s why security and compliance are key focus areas for our organization and product development.

Rapid implementation & validation

Implementing quality management software in life science organizations has changed dramatically. Leverage our team of industry veterans as we guide you from zero to quality hero in as little as 4 weeks.