Accelerating Compliant Equipment Testing Through Automation

Manual validation slowing manufacturing performance

A manufacturing client operating in a GMP-regulated environment relied on a large suite of repetitive, paper-based tests executed whenever equipment modifications were introduced.

The process was resource-intensive and dependent on user diligence. Engineers were required to prepare, approve, physically execute, and post-approve tests manually, increasing the risk of delays and human error.

Testing also depended on equipment functioning without unrelated disruptions that could affect product quality during execution. The client needed a solution enabling revision-controlled test templates with full audit trails, automated equipment interaction, and compliant report generation confirming valid results.

A structured and compliant automation platform

NNIT developed a C# Windows Presentation Foundation (WPF) application enabling engineers to design tests using a Sequential Function Chart structure, with step logic written in Python.

The platform introduced reusable, revision-controlled test templates subject to approval workflows and full audit trails before execution. Test execution required enforced electronic signatures, ensuring regulatory compliance.

Upon completion, the application automatically generated inspection-ready reports documenting observed values and clear pass/fail outcomes. By standardizing and automating validation, the solution reduced regulatory risk, improved data integrity, and accelerated equipment release to production.

Driving measurable operational impact

The implementation delivered significant operational improvements:

• 72.2% average reduction in testing time (March–December, 9 months).

• 2,277.5 hours saved, equivalent to €156,988.08 during downtime in the same period.

• Estimated €209K annual savings in test execution during downtime (scaled to 12 months).

• Testing resource requirements reduced from four personnel to one, improving workforce efficiency.

Beyond cost savings, the automation minimized human error and reduced the risk of product quality issues linked to manual execution.

Driving change together

NNIT’s knowledge of OT equipment, IT infrastructure, and industrial communication protocols ensured robust system integration and reliable execution across manufacturing environments.

Through close collaboration and continuous feedback, NNIT delivered multiple releases with expanded functionality and equipment connectivity, ensuring the platform evolved alongside business needs.

The result is a scalable digital validation platform that strengthens compliance, improves operational efficiency, and supports faster return to production.