Achieve compliance excellence in the healthcare and life sciences industries
19 of 20
top Life Sciences companies are OpenText customers
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.
Continually comply with regulations and GxP best practices with paperless and automated processes, and embed compliance into the product lifecycle.
Ensure more effective testing with a risk-based approach, and identify focus areas with risk analytics.
Manage regulatory requirements relationships, trace them to tests and defects, and use an audit log to track the history of all validation artifacts.
Protect digital records with e-signatures, and embed automated workflows and rules into daily quality assurance activities.
Apply advanced analytics to validation data to gain real-time insights for continuous improvement and informed decision-making.
Use a REST API to feed real-world data from devices, and digitize offline manual testing results with QoT.
Allow employees, partners, and suppliers to collaborate on validation from anywhere—regardless of cloud or off-cloud deployment.
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.
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.
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.
See how customers are succeeding with ALM-based GxP validation solutions.
See more success storiesOpenText offers a choice of products to manage GxP validation:
OpenText combines end-to-end solution implementation with comprehensive technology services to help improve systems.