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ALM-Based Computer System Validation

Achieve compliance excellence in the healthcare and life sciences industries.
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Don’t let paper-based Computer System Validation drag you down. Gain momentum with OpenText ALM-based digital processes.

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Benefits

Risk-Based Quality Management

Use a risk-based approach for more effective testing and leverage risk analytics to identify focus areas.

Complete Traceability and Audit Log

Trace from regulatory requirements to tests and defects, and track the relationship and history of all validation artifacts.

Solid Processes with Electronic Signature

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

Data Transparency and Real-Time Insights

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

Integrated Electronic Records from All Sources

Use a REST API to feed real-world data from devices and digitize offline manual testing results with QoT.

On-Prem and SaaS Collaborative Platform

Collaborate with employees, partners, and suppliers on validation, from anywhere—whether you deploy on premises or subscribe to OpenText SaaS.

Leaders trust OpenText

See how customers are succeeding with Computer System Validation solutions.

 

  • Case Study

    Xellia Pharmaceuticals

    Digitize Good Practice validation and cut testing time by 70 percent.

    Read about Xellia Pharmaceuticals
    Xellia Pharmaceuticals image
  • Case Study

    UCB

    Have substantial efficiency and compliance gains in non-IT equipment verification.

    Read about UCB
    UCB Case Study Image
  • Case Study

    Bon Secours

    Deliver a superior patient experience and enhanced team collaboration in an agile environment.

    Read about Bon Secours
    Bon Secours Case study image

    ALM adoption across the pharmaceutical industry

    • ALM adoption continues to increase across the pharmaceutical and adjacent industries where process validation is critical.
    • Adoption is primarily driven by digital transformation projects and paperless agendas – requiring a unique set of capabilities.
    • Numerous purpose-built features in ALM support validation requirements coupled with a strong roadmap for ongoing innovation.
    Leading pharmaceutical companies use ALM

    Products and Services

    ALM/Quality Center

    Govern application lifecycle management activities and implement rigorous, auditable lifecycle processes.

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    e-Signature Implementation Service

    Electronically sign every human interaction, like rejection or approval, to stay compliant and efficient.

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    ValueEdge

    Our SaaS platform features continuous quality, DevOps, and value stream management.

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    ALM Octane

    Practice agile and DevOps while meeting stringent regulatory requirements.

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    Quality of Things (QoT)

    Conduct manual tests anywhere while not connected to ALM server and keep track of your execution results digitally without paper.

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      • “Although our paper-based test processes worked, it would be time-intensive to deliver the required information during authority inspections. Now, our transparent system shows our inspectors we are in control of our processes and fully confident in the information we share.”

        Per Bischoff Kristiansen
        QA IT COMPLIANCE SPECIALIST
        Xellia Pharmaceuticals

      • “Our secure agile testing processes with ALM Octane and Fortify help us deliver a superior patient experience, especially during COVID-19.”

        Christopher Christian
        Quality Assurance Analyst Bon Secours
        Mercy Health

        Resources

        Report
        Micro Focus Recognized as a Leader in GigaOM Radar RSLM Report

        Micro Focus (now OpenText) has been named a leader in regulated software lifecycle management (RSLM). Learn how our market-leading solutions support your business needs.

        Read report
        Web page
        ALM/Quality Center Use Cases in Regulated Industries

        Navigate ever-changing regulations and reduce workforce costs with ALM/Quality Center.

        View web page

          Want to achieve continuous compliance?

          Talk to an expert about how ALM/Quality Center helps.

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