A global pharmaceutical manufacturer needed to replace paper-based batch records with a validated electronic system. Legacy processes created audit risk, slow release cycles, and inconsistent operator workflows across multiple production lines.
Implemented a fully validated electronic batch record system with audit trails, digital signatures, and role-based access control for a global pharmaceutical manufacturer.
A global pharmaceutical manufacturer needed to replace paper-based batch records with a validated electronic system. Legacy processes created audit risk, slow release cycles, and inconsistent operator workflows across multiple production lines.
Maestrotek deployed a Part 11-compliant batch execution platform with electronic signatures, role-based access, and immutable audit trails. The solution integrated with existing MES and LIMS systems while providing guided workflows for operators on the plant floor.
The customer achieved faster batch release, reduced documentation errors, and passed regulatory audits with full traceability. Validation documentation was delivered alongside the platform to accelerate go-live across sites.
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Talk to our team about how Maestrotek can deliver similar outcomes for your operation.