Introduction: 

Our client initiated a digital transformation program to replace paper-based batch records with an electronic batch record solution built on the Tulip manufacturing application platform. The initiative covered both primary and secondary packaging operations. By standardizing execution through applications, manufacturers can significantly improve overall equipment effectiveness while maintaining strict regulatory compliance.

Digital batch initiation and guided execution reduce manual interventions, minimizing errors, deviations, and rework. Real-time visibility into line readiness, material availability, and equipment status enables faster decision-making and reduces unplanned downtime, directly impacting throughput and time-to-market. From a quality and compliance perspective, built-in verification steps and in-process controls strengthen data integrity and ensure consistent adherence to cGMP requirements. Electronic records generated during execution streamline quality review and batch release, reducing administrative effort and inspection risk.

This Whitepaper outlines the approach taken to implement the digital solution in a live production environment. It intentionally excludes any client-specific or proprietary information.

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