Opkey
22 Case Studies
A Opkey Case Study
Sparta Systems, a leading quality management software provider for pharmaceutical and life sciences ( Trackwise & Trackwise Digital), was performing all internal validation testing manually and needed an automation tool to support an Agile development cadence. Facing limited test coverage, heavy reliance on technical resources, and strict regulatory requirements (21 CFR Part 11, HIPAA, GxP), Sparta Systems turned to Opkey to automate their Computer Systems Validation (CSV).
Opkey provided a GxP-compliant solution with a no-code process builder, self-healing test scripts, and a Trackwise-specific automation library, enabling business users to create and maintain tests without developers. Using Opkey, Sparta Systems automated 290 Operational Qualifications, cut release validation time by 50%, automated 70% of tests, achieved in-sprint test automation, and established an official partnership with Opkey.
Bruce Kratz
Vice President of Research and Development