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ALM-Based GxP Validation

Achieve compliance excellence in the healthcare and life sciences industries.
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Need to comply with GxP ("good practice" quality standards and guidelines)? Don’t let paper-based validation drag you down. Gain momentum with OpenText™ ALM-based digital processes.

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 GxP compliance solutions.

 

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.

e-Signature Implementation Service

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

ValueEdge

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

ALM Octane

Practice agile and DevOps while meeting stringent regulatory requirements.

Quality of Things (QoT)

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

  • “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
  • “OpenText solutions reduce the time and effort associated with testing, and crucially help us to ensure that all of our systems, machines and manufacturing devices are functioning perfectly, helping us to maintain a great safety record and phenomenal quality .”

    SPOKESPERSON
    Spokesperson
    Leading Biotechnology Company

Resources

Flyer
Achieve Compliance Excellence in Healthcare and Life Sciences Industry

Gain momentum with ALM-based digital processes to continuously stay compliant.

Web page
ALM/Quality Center Use Cases in Regulated Industries

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

Frequently Asked Questions

Want to achieve continuous compliance?

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

release-rel-2024-3-1-9400 | Thu Mar 14 23:51:15 PDT 2024
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release/rel-2024-3-1-9400
Thu Mar 14 23:51:15 PDT 2024
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