OpenText Core for Quality Management
Simplify quality processes for efficiency and compliance
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.
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.
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