EBR systems are software-driven solutions for managing record-keeping and review workflows, which eliminate the time-intensive extraction, checking, and analysis steps associated with paper-based batch record processes.
These efficient and agile systems are not simply an electronic equivalent to outdated paper-based documentation (often referred to as ‘paper on glass’ solutions). Instead, they transform how pharmaceutical manufacturers operate by enabling real-time data collection and ensuring strict execution of batch processes, thereby improving the quality and consistency of data and supporting GMP compliance. Looking to grow its product line, Nephron urgently required a solution.
However, previous attempts at finding an affordable EBR that met its business needs had proven unsuccessful. Commercially available paperless systems were either pure ‘paper on glass’ equivalents or designed from an automation perspective without the possibility of user-mediated configuration.
Maintaining such a system was complex and required extensive investment in IT resources, which was simply not cost-effective for a small-to-medium-sized company like Nephron. When Nephron discovered that its existing supplier, Lonza Informatics, was developing a new EBR system for pharmaceutical manufacturers — the MODA-ES™ Platform — a collaboration evolved, based on the partners’ mutual requirements.
The collaborative approach taken by Lonza and Nephron, with parallel implementation and robust testing of multiple beta versions of the software, enabled this expedited software roll-out. Nephron was delighted to partner with Lonza and reports finding their MODA-ES™ Platform to be an affordable solution that delivered excellent ROI.
Reporting on how its performance exceeded Nephron’s expectations, Bryan Beck noted, “The 6-hour review needed for paper batch records was reduced to an hour with the MODA-ES™ Platform, so it increased our efficiency significantly. The MODA-ES™ Review and approve process allows for real-time review as the batch advances through the product lines from formulation through packaging.