Transforming CDMO data siloes into real-time manufacturing oversight

Data siloes limiting external manufacturing transparency

The manufacturer relied on a CDMO operating a high-volume combination drug product line. However, variation across supply chain, metrology, process, and quality functions was siloed and unavailable for integrated data analysis.

 This lack of visibility limited the company’s ability to detect variance and risk within the manufacturing process and restricted oversight of externally produced batches. Manual handling and fragmented reporting further increased effort and reduced confidence in data consistency across organizations.

 A structured approach to compliant data integration

To address these challenges, NNIT supported the CDMO in expanding its Ignition Batch Solution with a Data Transfer System interfacing with five external data sources. The solution captured batch-relevant process, component, assembly, and quality inputs and tracked them through an automated workflow covering data capture, archiving, and export to the pharmaceutical client’s private AWS cloud.

 Comprehensive system logging ensured full traceability, including data source monitoring and confirmation of successful transfers. This enabled the end customer to gain full external manufacturing insight and perform advanced analytics across one or multiple CDMO lines without disrupting existing operations.

 Driving transparency through IT/OT convergence

By combining deep domain knowledge in IT/OT convergence with technical expertise in compliant reporting solutions, NNIT led the design and alignment process between CDMO and end-user requirements. From solution design to scalable implementation, NNIT ensured the platform could be replicated across multiple CDMO operations while maintaining compliance and audit readiness.

 The result was a lean, automated workflow leveraging existing architecture to present aligned, real-time data in a state ready for audit and advanced analytics – demonstrating NNIT’s ability to bridge manufacturing complexity and digital oversight for measurable business value.