Challenge
The rare-disease pharmaceutical manufacturer needed to modernize highly regulated production by reducing paper, rework and deviations while strengthening cGMP compliance, traceability and process visibility across multiple sites in North America and Europe.
Solution
IndX led a multi-year rollout of a customized Siemens Opcenter Execution eBR MES, providing validation support to GAMP standards, go-live leadership, end user training and ongoing administration to enable paperless batch record management and consistent, controlled operations across sites.
About the Project
IndX has worked with the customer over the past 7 years to help them digitalize their manufacturing, automating processes and reducing the use of paper by 90% at facilities across North America and Europe. To achieve this transformation, our team of experts led a multi-year, multi-site effort to customize and implement a full-featured Manufacturing Execution System (MES) with Electronic Batch Records (EBR) management capabilities at various existing and greenfield plants.
IndX's Advantage
Thanks to the digitalization of their manufacturing process, the customer's operations have become significantly more efficient and controlled. Digital Manufacturing means most quality checks happen in seconds, not hours. This speeds up production and enables the customer to produce more medicine at higher quality specifications. As a result, medicine that is critical for those suffering with some of the most debilitating diseases in the world can get to more people, faster and at a lower cost to both the manufacturer and the patient.
IndX has had a consistent presence in the life science industry, including pharmaceutical and medical device manufacturing, for over a decade. The industry has historically been characterized by a reluctance to change processes and adopt technology due to regulatory constraints and pressures. This approach has started to change in recent years, however, as the FDA and international regulatory agencies have started to embrace innovation more and more. IndX has been on the forefront of this transformation, guiding manufacturers and facilitating the adoption of Industry 4.0 technologies aimed at improving quality, reducing patient risk and increasing data transparency.