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CASE STUDY

Pharma Manufacturer: MES + ITOM Integration for FDA-Validated Operations

A global pharma manufacturer integrated MES + ServiceNow ITOM with full 21 CFR Part 11 audit trail. Validated-systems uptime sustained at 99.99%.

May 9, 2026 · 2 min read · By admin
At a glance
99.99% CHANGE
Industry
Pharmaceutical
Topics
Compliance · ITOM · Servicenow
Published
May 2026
Headline outcome
99.99% Validated-systems uptime: 99.99% sustained

Measured outcomes

What this programme actually delivered.

99.99%

Validated-systems uptime: 99.99% sustained

21

21 CFR Part 11 audit trail: complete + automated

64%

Quality-event response time: down 64%

The challenge

A global pharma manufacturer’s validated systems (MES, LIMS, batch-record systems) had to maintain regulatory uptime while supporting modern incident-management practices. The two requirements often conflicted.

What we built

ITOM integrated with validated MES + LIMS systems with full 21 CFR Part 11 audit trails. Change-control workflows preserve validation lifecycle. Quality-event detection automated.

Outcomes

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