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Mergen named ServiceNow Elite Partner and Center of Excellence of the Year

Measured outcomes

What this programme actually delivered.

51%

CAPA cycle time: down 51%

3

FDA inspection: zero findings over 3 cycles

21

21 CFR Part 820 audit-readiness continuous

The challenge

A medical-device manufacturer’s quality management ran on a legacy QMS that struggled with FDA QSR requirements at scale. CAPA cycles were slow; investigation documentation was inconsistent.

What we built

ServiceNow-based QMS aligned to FDA QSR. CAPA workflow with stage-gated investigation. Document-control with audit trail. Trending + analytics for quality patterns.

Outcomes

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