How a Top 5 Global Pharma Company Achieved 100% Traceability in One Week

Pain Points: Manual Traceability Made Validation Time-Consuming

One of the world's largest pharmaceutical companies needed to perform computer system validation (CSV) on a configurable off-the-shelf platform used to develop an in vitro diagnostic (IVD). The evidence (requirements, test cases, and results) already existed in their tools, but only 30% of requirements were traceable.

• Only 30% of requirements traced to their verifying tests: Coverage gaps were indistinguishable from out-of-scope requirements or unlinked tests.
• Validation meant rebuilding evidence by hand: Every fix required sign-off across multiple teams, making validation slow, repetitive, and error-prone.

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Solution: Faster Validation, More Time for Quality

Ketryx connects directly into the team's existing Jira Data Center and Xray environment, enabling continuous compliance where teams already work, with documentation generated in the background.

• 48 hrs from go-live to first value: GxP compliance is built into existing workflows, so requirements, tests, and trace relationships are captured as teams work, streamlining manual approvals.
• 100% traceability up from 30% in one week: A live view of the trace matrix separated real gaps from out-of-scope requirements and unlinked tests, giving the team real-time visibility that let them close 80% of missing links in a day.
• 40% reduction in project time: Reusable, connected validation carries system requirements across qualifications and links them to the IVD product itself, so each validation builds on the last.