ALM-based GxP Validation
Achieve compliance excellence in the healthcare and life sciences industries
19 of 20
top Life Sciences companies are OpenText customers
Streamline compliance with a digital approach
Organizations in healthcare, life sciences, food, and other regulated industries must adhere to good practice (GxP) qualities and standards. But many of these organizations still use paper-based validation methods, wasting valuable time and resources and increasing the risk of non-compliance.
ALM-based GxP Validation solutions leverage digital processes so regulated industries can securely and efficiently ensure compliance. Enable collaboration, gain analytics-driven insights, and unlock full tracking and traceability with a modern approach to GxP validation.
Key benefits
Continually comply with regulations and GxP best practices with paperless and automated processes, and embed compliance into the product lifecycle.
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Enhance quality management
Ensure more effective testing with a risk-based approach, and identify focus areas with risk analytics.
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Gain better traceability
Manage regulatory requirements relationships, trace them to tests and defects, and use an audit log to track the history of all validation artifacts.
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Streamline validation processes
Protect digital records with e-signatures, and embed automated workflows and rules into daily quality assurance activities.
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Unlock data transparency and insights
Apply advanced analytics to validation data to gain real-time insights for continuous improvement and informed decision-making.
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Integrate electronic records from all sources
Use a REST API to feed real-world data from devices, and digitize offline manual testing results with QoT.
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Enable collaboration
Allow employees, partners, and suppliers to collaborate on validation from anywhere—regardless of cloud or off-cloud deployment.
Business impacts
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GxP validation time
GxP validation is required to ensure regulatory compliance. Paper-based validation processes are slow, costly, and complicated. Save significant time and money with ALM-based digital processes.
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Audit readiness
Systems subject to GxP validation must work as intended. To ensure they do, auditors demand a clear, comprehensive test history, which manual validation processes often struggle to provide. Digitize validation for compliance and audit readiness.
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Non-IT equipment verification
GxP validation targets both software and non-software in a system. Without a wholistic approach, organizations risk low efficiency and consistency. Adopt a proven test management solution to verify all components and get a true picture of quality.
Leaders trust OpenText
See how customers are succeeding with ALM-based GxP validation solutions.
See more success stories
OpenText™ ALM supports digital transformation to deliver life-saving drugs faster by reducing application testing time by 30–40%
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Medicines manufacturer ensures rigorous, auditable CSV software testing for life-saving work with OpenText ALM/Quality Center and OpenText UFT One
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Products
OpenText offers a choice of products to manage GxP validation:
- OpenText™ ALM Quality CenterQuality governance, auditable processes
- OpenText™ ValueEdge™End-to-end, AI-powered value stream management and DevOps platform
- OpenText™ ALM Octane™Deliver quality across your DevOps pipelines
Professional Services
OpenText combines end-to-end solution implementation with comprehensive technology services to help improve systems.
- OpenText Consulting ServicesConsulting Services
- OpenText Professional ServicesExplore Professional Services
- OpenText Packaged ServicesPackaged Services
