Case Study: Leading Biotechnology Company achieves rigorous, auditable CSV testing and streamlined compliance with OpenText ALM/Quality Center and UFT One

Medicines manufacturer ensures rigorous, auditable CSV software testing for life-saving work with OpenText™ ALM/Quality Center and OpenText™ UFT One

A leading biotechnology company that develops and manufactures medicines worldwide faced the challenge of validating hundreds of computer-based systems that directly or indirectly affect patient safety. With operations in 100+ countries and strict regulatory requirements (GAMP 5, ALCOA+, US FDA 21 CFR), the organization needed rigorous, auditable Computer System Validation (CSV) processes—but manual evidence handling, physical signatures and complex test management for ~3,500 users made compliance slow and cumbersome.

The company deployed OpenText ALM/Quality Center (SaaS) integrated with UFT One and an e‑Signature solution to centralize requirements, link tests, capture run evidence, automate ~15% of ERP functional tests, and enable electronic approvals. The result was streamlined, reusable testing workflows, stronger traceability and granular audit logs, faster testing cycles with cloud-based maintenance savings, and a single digital record that makes audits and regulatory reporting far more efficient.