Case Study: Abbott Laboratories achieves FDA-compliant digital signatures and streamlined QA with OpenText eSignature

Abbott Laboratories - Customer Case Study

Abbott Laboratories, a global $20B healthcare company known for diagnostics, medical devices and pharmaceuticals, faced a critical quality-assurance challenge: FDA-required authenticated test records. Abbott’s QA workflow used IBM Rational DOORS and Micro Focus ALM/Quality Center, but a third-party digital-signature plug‑in was unreliable—breaking with ALM upgrades, creating interface issues, and requiring 3–4 months of installation, debugging and validation for each upgrade.

Abbott replaced the third‑party tool with Micro Focus eSignature fully integrated into ALM and Quality Center. The integrated solution met FDA authentication requirements, removed the overhead and unpredictability of managing a plug‑in, and freed IT resources. Abbott now manages software and hardware verification end-to-end, supports 2–4 major and 10–12 incremental projects per year, and is positioned to expand its ALM user base as testing grows.

Abbott Laboratories