Digital Manufacturing for Pharmaceuticals

About the Customer

The customer is a global pharmaceuticals company and manufacturer focused on the treatment of rare diseases like hemophilia and primary immunodeficiency. The company's products are available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders and Oncology, amongst others.

Customer
Pharmaceutical Developer
Location
North America & Europe
Industry
Pharmaceuticals & Life Sciences
Siemens Opcenter Execution Pharma

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.

Project Activities 

  • Designed and deployed a customized MES for electronic batch record management using Siemens Opcenter Execution (SIMATIC IT) eBR
  • Led multi-site implementation efforts across existing and greenfield plants in North America and Europe
  • Provided consulting and technical leadership before, during and after system go-live at each facility
  • Supported computer system validation activities in alignment with GAMP standards
  • Delivered end user training and adoption support to ensure consistent system usage
  • Performed remote MES administration to maintain system stability and performance
  • Maintained and enhanced the MES solution through ongoing technical support and continuous improvement services

Business Drivers 

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Achieve paperless manufacturing process
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Global standardization of plant systems
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Reduce rework, deviations, research time and costs through automated error checking and process controls
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Improve regulatory compliance driven by built-in cGMP features and complete manufacturing traceability
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Improve process visibility with built-in GxP reporting and genealogy features
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Ensure internal end user adoption and acceptance

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.

Julian Stutley

Commercial Development Director - EMEA
Julian is a sales and business development professional at IndX with cross-industry experience across pharmaceuticals, agrochemicals, tobacco and the not-for-profit sector. He leads key account management across the EMEA region and supports IndX’s commercial and go-to-market strategy, with a strong focus on building trusted customer relationships and delivering practical value through digital supply chain and serialization solutions.
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