Drive continuous improvement with the quality event and CAPA solution built for scaling life science companies. Define, address, and manage the root cause of the problem and prevent future issues.
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Easily report and document the many different types of quality events your organization manages. Whether it’s documenting customer complaints or reporting incidents on the shop floor, you need a system that you can rely on and one that demonstrates consistency and control to an auditor.
Quality event types supported:
Customer complaints
Quality incidents
Out-of-specificiations
Deviations
Non-conformances
Audit observations
Inspection findings
Custom event types
Improve visibility into your organization’s quality health through reporting and trending of data. Mobilize your entire workforce to capture and track events or issues, from reporting to resolution, in one central quality management system.
Access on any device
Enjoy the freedom to access your information securely from anywhere, at any time, and on any device.
Configurable event types
Centrally manage all of your organization’s quality event types, pre-defining reviews and approvers per event type, department, or business unit.
Flexible dashboards and reports
Flexible dashboards and exportable reports help to ensure that you're staying consistently audit-ready.
Action planning & tracking
Create, allocate, and track actions with clear due dates to ensure that CAPAs are executed effectively and efficiently.
Native integration with Microsoft Office
Seamlessly connect your quality environment to your operations with native Microsoft 365 and Office integration.
Records center for archiving
Easily keep track of document management activity with a digital records center designed to make archiving completed records a breeze.
Integrated with our other QMS modules
Create a closed-loop quality ecosystem by connecting your core quality processes together and move closer to continuous improvement benchmarks.
Built-in PDF conversion engine
Speed up file conversion and avoid third party tools by leveraging a built-in PDF conversion engine.
Real-time quality reporting
Get the insights you're missing. Find out what's impacting quality standards faster and improve operational excellence.
Standardized electronic forms
Improve event reporting and CAPA management through carefully-crafted digital forms that adjust dynamically to the different events your team is reporting.
Root cause analysis
Perform root cause analysis and associate actions to corrective and preventative actions and promote continuous improvement.
Task delegation & notifications
Cut down your to-do list with automated tasking, completion monitoring, and reminder notifications.
Intuitive investigation tasks
Create, manage, and track your incident investigation process from a centralized dashboard with full audit-readiness.
Google-like search & retrieval tools
Make finding and retrieving documents as simple as looking up a nearby restaurant with Google-like search tools.
CAPA planning tools
Streamline CAPA business processes with integrated and dynamic forms to support better planning and execution.
CAPA software is a category of application that allows life science companies to digitally manage the reporting of quality issues or events, manage tasks, and implement corrective and preventative actions to resolve issues within your quality processes. With full audit trail functionality, easy-to-use digital forms, and custom reporting, CAPA software gives you the functionality your team needs to have a documented and robust CAPA process.
The regulatory requirements aren't in place don't demand perfection, but what they expect you to ensure there are well-defined business processes in place, and that your team tackles quality issues head-on and focuses on continuous quality improvement. Montrium's CAPA software provides tailored functionality to help report quality issues as they occur, capturing all of the key information as defined by your quality management processes.
Both root cause analysis (RCA) and corrective and preventive actions (CAPAs) are tools used to be able to resolve quality issues that occur. However, corrective and preventive actions are processes that quality teams use to collect and analyze information for the purpose of identifying quality problems, and correcting issues at-hand and preventing recurrences. Root cause analysis typically looks at actions that need to be taken that go beyond the immediate problem. It focuses in on uncovering the underlying cause(s) of a problem and forms the link to the corrective and preventive actions.
Typically, there are two different types of CAPA process that quality teams undertake in Montrium's CAPA software. The corrective action is an action taken to eliminate the causes of quality issues in order to prevent recurrence. The preventive action CAPA software component is managing the actions that are taken to prevent the occurence of quality issues generally resulting from an internal risk assessment or analysis.
All of Montrium's applications form a complete quality management system that scaling life science teams can leverage to manage end-to-end quality processes and focus on continuous improvement. Check out our other quality management software applications here.
As an output to the different steps in your CAPA processes, Montrium's CAPA software creates a series of records that are approved and filed as records. Baseline document management functionality is included as standard.
Through a series of digital forms that dynamically change based on user inputs, quality teams can leverage Montrium's corrective action software to perform and capture any root cause analysis information. Root cause analysis is a key component of continuous improvement, which is a critical focus for quality teams.
Montrium's CAPA management software is an important component of its enterprise quality management software application. With other modules for document control, training management, and change control, our CAPA management software completes a robust and comprehensive quality management software for life science organizations.
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.
Implementing software in the life sciences has changed dramatically.
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as little as 4 weeks.
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