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OpenText Core for Quality Management

Simplify quality processes for efficiency and compliance

Learn more about Core for Quality Management

What is corrective and preventive actions management

Quality management is the foundation of every Life Sciences company. It serves as the framework for consistent operations and compliance with the extensive regulations that ensure patient safety and product quality. Key to compliance is the ability to assess deviations from these requirements and implement effective corrective and preventive actions (CAPA) to address them.

OpenText Core for Quality Management overview

OpenText Core for Quality Management automates the responses to nonconformance and CAPA events, while ensuring that associated and controlled documents are up to date. The cloud-based application natively integrates with OpenText content management systems, seamlessly linking quality management systems (QMS) and enterprise content management (ECM) systems at logical points in the process.

OpenText Core for Quality Management features

  • Nonconformance and CAPA processes

    Workflows manage processes with clear, role-based ownership for tasks and deliverables based on industry best practices.

  • Seamless content management integration

    Search-and-link functionality connects documents that need to be updated or referenced as part of a CAPA plan, dramatically simplifying navigation and reducing manual effort.

  • Insightful quality metrics

    Automatic tracking of key quality data points provides live trends on issue classification, risk, recurrence and process improvement.

  • Embedded root cause analysis tools

    Leverage tools that guide users through problem analysis techniques to assist during the complex processes of issue investigations and root cause determination.

  • Qualified cloud deployment

    Deployed on a qualified, controlled infrastructure certified against ISO and SOC requirements, the cloud-based SaaS application offers a favorable starting point for a risk-based approach to validation.

Benefits of OpenText Core for Quality Management

  • Intuitive user experience

    Eliminate delays in completing nonconformance and CAPA tasks resulting from time spent navigating complex systems and cumbersome processes for compiling core content.

  • Improved CAPA investigation visibility

    Deliver insightful quality metrics and embedded analytical tools that facilitate reporting for analysis and audit readiness. Identify root causes to create effective mitigation measures.

  • Increased compliance and control

    Ensure readiness for regulatory inspection with on-demand records and detailed audit trails. Support electronic record/electronic signature (ERES) requirements with permanent history logs, encrypted, time-stamped electronic signatures.

  • Extend investments

    Leverage existing on-premises investments with a cloud-based application. Connect quality processes to the content repository to ensure a single authoritative source for regulated content across the Life Sciences organization.

  • Cloud deployment

    Accelerate readiness and availability with lower total cost of ownership using a qualified infrastructure and validated installation.

Contact us to speak with a member of the Life Sciences team