Clinical Batch Release Management
Life Sciences, Integration and API Services
This Enterprise Biotechnology company’s Product Development & Manufacturing (PDM) functional units outsourced its clinical batch manufacturing and testing. Information on batch manufacturing activities sent back to its ERP and Quality Systems were manually entered into Excel spreadsheets and exchanged via emails to track and disposition batches. This manual process created discrepancies and duplication resulting in operational inefficiencies.
The itsoli team engaged with business stakeholders to define the problem and envisaged a different approach to conduct the business. The team built a solution that automatically integrated with the company’s ERP, Study Management Systems, and Quality Management Systems to track batch activities at the inception, approval, assignment, tracking, and release stages. The solution allowed management and operational personnel immediate visibility from a single source of truth. It utilizes Business Intelligence dashboards to analyze and measure performance improvements, workload forecasts, and operational efficiencies/gaps at every stage of the batch release process. The solution also provided an electronic tracking system to automatically prioritize batches for different groups based on incoming data feeds.
Results
itsoli developed a transformational in-house prescriptive solution that created synergies between different functional groups to effectively track clinical batches from inception to release. The application achieved over 80% operational efficiencies for the business and eliminated emergency batch releases. The solution was deployed at 30% of the cost of a similar COTS software. Employee performance increased 43% with handling volume increases of up to 150%.
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