Case Study: European-based Pharmaceutical Company achieves ISA88 batch compliance excellence with UST Global

European-based Pharmaceutical Company remediates ISA88 batch records in 90 days with UST Global

A European-based pharmaceutical company faced serious operational and compliance risks after an internal audit uncovered inconsistencies in its ISA88 batch record standards across 12 production facilities. The company engaged UST Global to create a batch record remediation program to reduce these business risks.

UST conducted a root cause analysis and devised a multi-pronged approach, developing a best practice strategy for ISA88 batch record management. UST helped the company address all compliance issues in less than 90 days and roll out the new system across all global manufacturing facilities within 18 months. This transformation ensured rigorous compliance, reduced risk, and led to greater production efficiencies, consistent product quality, and excellent safety.