Solutions

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

Watch how you can boost GxP validation efficiency with ALM-based digital processes

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.

  • Enhance quality management icon

    Enhance quality management

    Ensure more effective testing with a risk-based approach, and identify focus areas with risk analytics.

  • Traceability icon

    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.

  • Streamline process icon

    Streamline validation processes

    Protect digital records with e-signatures, and embed automated workflows and rules into daily quality assurance activities.

  • Unlock icon

    Unlock data transparency and insights

    Apply advanced analytics to validation data to gain real-time insights for continuous improvement and informed decision-making.

  • Integrate data icon

    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.

  • Collaboration logo

    Enable collaboration

    Allow employees, partners, and suppliers to collaborate on validation from anywhere—regardless of cloud or off-cloud deployment.

Business impacts

  • 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.

  • 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.

  • 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.

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Leaders trust OpenText

See how customers are succeeding with ALM-based GxP validation solutions.

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Explore the components of the solution

Products

OpenText offers a choice of products to manage GxP validation:

Professional Services

OpenText combines end-to-end solution implementation with comprehensive technology services to help improve systems.

ALM-based GxP Validation solution resources

OpenText e-Signature for ALM Octane and ALM/Quality Center

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Computer system validation made easy

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