Multi-site Class-A transformation


Client Type A biologics manufacturing network
Function Achievement of Class-A status over phased pilots and standardization by driving multi-site operational maturity.
Challenge Inconsistent standards across sites
Impact Four sites achieved Class-A

Challenge

A biologics manufacturing network grew rapidly but sites operated with different standards and disputed performance claims. Sponsor sought a single ERP, comparable metrics and Class-A performance.

Approach

We defined Class-A process standards and metrics, built workflows for SAP/ERP and BI reporting, implemented training and behavior change programs and ran pilot site rollouts. We coached process owners on achieving and sustaining Class-A KPIs.

Impact

One site achieved Class-A in 2 years, another in 3 years and two more in 4 years; sites reported improved yield, predictable batch costs and stronger margin visibility.

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