Jan 18, 2021
About the Customer
The customer is one of the largest multinational Pharmaceutical Manufacturing companies in the world. Over the years, our team has worked with many different divisions of their business as a strategic partner for Industry 4.0, including with their world-renowned innovation groups for blood fractionation, bio-pharmaceuticals and intravenous immunoglobulin production. For this digitalization project, our North American Industries eXcellence team partnered with the customer’s albumin manufacturing group in order to help transform the quality and efficiency of their plant operations by going paperless.
The Customer's Need
The customer’s decision to transition from a paper-based plant to a fully automated Manufacturing Operations Management system was accompanied by a specific set goals. The customer wanted to achieve:
- Ensured compliance with pharmaceutical manufacturing quality and reporting standards
- Standardization and streamlining of manufacturing processes and workflows
- Improved enforcement and control over plant activities and workflows
- Better performance reporting and insights
- Fewer errors in the entry of quality and production data
- Integration with their existing ERP system for inventory control
About the Project
In order to ensure a successful journey to paperless manufacturing, the customer partnered with the Engineering team. Our experts were brought in to lead the implementation and integration of a fully automated Manufacturing Execution System (MES) with Electronic Batch Record capabilities at the customer’s main albumin production facility in the U.S.
The solution delivered by our team was based on Siemens Opcenter Execution Pharma, a leading MES designed to meet the specific needs of the bio-manufacturing environment, and offering robust, pre-validated and pharma-specific capabilities which would ensure that the customer’s processes were always fully compliant with U.S. Food and Drug Administration and Good Manufacturing Practice (GMP) regulations.
Authorized users would be able to design Master Batch Records (MBRs) containing all the specifications needed to automatically generate complete Electronic Batch Records for quality assurance (step-by-step processes for production, ingredients and components, verification of each step according to SOPs, electronic signatures, etc.). The system would also allow the review of each albumin batch record by exception, providing a faster and more efficient release of products. Integration with the customer’s Enterprise Resource Planning (ERP) solution would ensure alignment between sales, planning and operations, and would facilitate resource and inventory optimization. The solution delivered would ensure manufacturing compliance with:
- ISA-95
- GAMP 5
- GxP
- cGMP
- 21 CFR Part 11
- Annex 11, Volume 4, Eudralex
Engineering's Advantage
Without a doubt, digitalization of factory processes was a huge driver behind the significant efficiencies the customer saw following the deployment of their new MES. The customer could finally rely on a stable and well-documented manufacturing process. Electronic Batch Recording meant that quality was built into the manufacturing process itself, rather than a by-product of it. At the same time, the creativity and end-to-end expertise our team of consultants and solutions architects brought to the table for this initiative proved indispensable to the delivery of a customer-specific solution designed for the unique nuances of their users, operations and business. Thanks to these capabilities, we were able to deliver a solution whose performance far exceeded the customer’s expectations, and provided a tremendous improvement of turnaround time from one production batch to the next.
- Paperless manufacturing
- Reduced time, cost and effort for compliance
- End-to-end process transparency
- Accuracy and consistency of batch records
- Fast product changes and new product introductions
- Fast information distribution and collaboration
- Identification and prevention of errors
- Minimized rework and investigation
- Instant analytics and trends
- Quality release-by-exception
