OpenText
1807 Case Studies
A OpenText Case Study
Xellia Pharmaceuticals, a global specialty drug manufacturer, struggled with a time‑consuming paper‑based testing process required by FDA cGMP rules. Manual, multi‑site sign‑offs and poor visibility meant testing often took weeks, defects were slow to be tracked and resolved, and releases faced last‑minute remediation.
Partnering with Scott/Tiger, Xellia implemented Micro Focus ALM with Agiliprove in a hosted environment to centralize requirements, test execution, electronic signatures and audit trails. The new workflow improved collaboration and defect resolution, cut application testing time by 30–40% (e.g., a serialization test finished in one week instead of a month), raised application quality and increased confidence during regulatory inspections.
Per Bischoff Kristiansen
QA IT Compliance Specialist