Nouveauté ! Développez votre produit SxMD avec un eQMS structuré comprenant des modèles SxMD prêts à être audités et conformes aux normes EU et US. En savoir plus !

CAPA software integrated in your QMS

Manage quality events with better control and visibility with an integrated CAPA software solution to enhance product quality.

Trusted by 200+ SxMD & Medical Device Companies

Audit-ready traceability at every stage

Demonstrate compliance with regulatory standards by ensuring that all quality issues and their resolutions are well-documented and easily traceable.

Faster resolution times with a single source of truth

Accelerate issue resolution with a unified platform that enables quick identification of trends and root causes with a collaborative CAPA software that allows the entire company to track actions, outcomes, and responsibilities, driving continuous improvement across all departments.

  • Gain access to comprehensive data analytics and reporting tools that provide actionable insights, helping to make informed decisions swiftly and reduce the recurrence of issues.

  • Simplify adherence to regulatory standards with automated documentation and audit trails, ensuring that every corrective and preventive action is traceable and verifiable.

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Matrix ALM

Automate your CAPA process

Streamline your CAPA process with automated workflows that manage quality events, documentation, and training seamlessly. This eliminates bottlenecks and ensures projects stay on schedule, enhancing overall efficiency.

  • Automation reduces human error and ensures consistent application of CAPA protocols, enhancing the reliability and accuracy of your quality management.

  • Automatically track progress and updates in real-time, enabling quicker responses to quality events and facilitating proactive management of your entire CAPA lifecycle.

Optimize CAPA outcomes with a closed-loop system

Enhance quality management by linking audit findings directly to corrective actions within a closed-loop system. This ensures that all audit results are swiftly actioned and impactful changes are implemented to improve overall quality.

  • Complete traceability of actions from inception to resolution increases accountability and ensures compliance with industry standards.

  • Systematically address and resolve audit findings and foster an environment of continuous quality improvement, reducing the likelihood of repeated issues.

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Proactive risk management

Safeguard your customers and reputation by proactively mitigating risks with a validation process that ensures corrective actions effectively address the root causes of non-conformities.

  • Implement validation gates to help confirm that all solutions not only resolve issues but also comply with regulatory requirements, enhancing safety and maintaining high standards.

  • Minimize operational disruptions and protect against financial and reputational damage with a CAPA software that enables rigorous validation processes to prevent the escalation of potential issues.

Systematic documentation

Utilize flexible templates to standardize the documentation process for CAPAs, ensuring that all non-conformities are recorded according to established guidelines, complete with crucial details such as location, identification date, and relevant stakeholders.

  • Standardized templates guarantee that every detail is consistently documented, enhancing the quality of data captured and facilitating effective issue resolution.

  • Streamlined documentation makes it easier to comply with regulatory requirements and simplifies the audit process, reducing the time and effort needed to demonstrate compliance.

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Executive control and insight

Empower your executive team with strategic oversight over the entire CAPA process, providing comprehensive insights into quality management metrics that drive business decisions and improve operational excellence.

  • Gain a clear understanding of how quality issues affect business outcomes, enabling informed strategic planning and resource allocation.

  • Access reports that highlight risk exposures and the status of ongoing corrective actions, facilitating proactive management and executive decision making.

Precision in quality assurance

Optimize your QA processes with a CAPA software that ensures precision and compliance, enhancing the reliability of quality assurance activities and safeguarding product standards.

  • Support compliance with detailed tracking of CAPA actions and outcomes, ensuring every quality event is accounted for and resolved according to regulatory standards.

  • Prepare for audits with confidence using tools that automatically document all QA activities and CAPA resolutions, making audit processes smoother and more predictable.

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Enhance product development

Equip your R&D team with advanced tools to preemptively address potential nonconformities, integrating seamless CAPA processes that support innovative product development and reduce time-to-market.

  • Identify potential quality issues during the development phase to enable timely interventions that preserve design integrity.

  • Leverage detailed CAPA data to refine product designs continually, ensuring that R&D efforts align with quality standards and market expectations.

Hear from our customers

“We use Jira to support our development process, and the Matrix Requirements solutions to track all our regulatory work. Integrating the two systems lets us display the latest requirements and specifications in Jira, stay on top of bug reports and take corrective and preventive actions.

Sofie Buysse, Product Owner, Byteflies