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OpenText Core for Quality Management

OpenText Core for Quality Management brings simplicity to CAPA management

Production & Process Controls and CAPA

  • 30% most frequently observed & cited by FDA

Most common pitfalls

  • Root cause determination
  • Reliable metrics documentation

(Source: FDA 2017)

Life Sciences companies report that nearly half of their quality processes are manual, which can be inefficient and error-prone and lead to increased risk of regulatory agency observations and manufacturing delays. When adverse events occur, organizations struggle to correctly isolate root causes. This is compounded by poor or nonexistent connections between systems, often from different vendors making them difficult to navigate.

OpenText Core for Quality Management delivers an intuitive, streamlined, and tailored user experience for completing nonconformance and corrective and preventive action (CAPA) tasks, making complex processes simple and efficient. The application ensures readiness for regulatory inspection with on-demand records, detailed reports and audit trails, reducing risk by eliminating manual quality processes.

Core for Quality Management natively integrates with OpenText content management systems, with no additional software installation or hardware investment, to ensure a single, authoritative source for regulated content across the extended organization. As a multi-tenant Software-as-a-Service application hosted in the OpenText Cloud, Core for Quality Management lowers the total cost of ownership by reducing validation and maintenance costs.

  • Intuitive, modern, experience with at-a-glance layout
  • Embedded root cause analysis tools and insightful quality metrics
  • Seamless Documentum integration with CAPA processes
  • Qualified cloud deployment
Core for Quality Management Explainer video

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  • Making complex processes simple and efficient with OpenText OT2

    Read the blog
  • Innovation in life sciences white paper thumbnail

    Innovation in life sciences quality management

    Read the white paper
  • OpenText Quality application overview thumbnail

    OpenText Core for Quality Management application overview

    Download the datasheet