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

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). With evidence scattered across disconnected tools, only 30% of requirements were traceable. By connecting directly to Jira Data Center and Xray, Ketryx delivered full traceability and release documentation within a week, with no data migration or workflow changes.

## Impact

Industry  
Pharmaceuticals  
Device Type  
Computer System Validation  
Tech Stack  
Jira Data Center, Xray

#### **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).

- **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.

#### **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.

## "The traceability matrix is incredible. We went from 30% to 100% traceability in a week for digital validation."

Top 5 Pharma  
Director of R&D

Building AI-Enabled Medical Software?

## Compliance is a control problem. Solve it inside the tools your teams already use.