Sector: Pharmaceuticals
A global player in the pharmaceutical industry wanted to extensively digitalize the Quality Control process for clinical production.
Expertise Moore
- Extensive experience in the pharmaceutical sector
- Guidance in digital transformation
- Change management
Customer Request
Speed, flexibility, and high-quality standards characterize the GMP production environment for clinical studies of this pharmaceutical industry leader. For years, the organization had relied on a manual, labor-intensive, and paper-based process for Quality Control.
The organization struggled with the workload, the high complexity of the Quality Control processes, and the relatively low compliance with internal work procedures. Therefore, the customer wanted to automate the Quality Control across the warehouses, laboratories, and quality department. To make this possible, it was necessary to integrate the ERP (Enterprise Resource Planning) system and the LIMS (Laboratory Information Management System).
This was not easy, as the global supply chain relied on both internal and outsourced production facilities. Furthermore, the IT systems had been heavily customized over the years. Moreover, the quality of the master data in both systems was inadequate. To manage the digital transformation in this challenging context, the producer sought the help of Moore Belgium.
Approach
For this customer, Moore designed a structured implementation process. The goal was to implement a fully automated Quality Control process that is driven by the systems, while reducing the workload and increasing quality. All of this had to be done in line with the GMP (Good Manufacturing Practices), the quality assurance system within the pharmaceutical industry.
The project began with a thorough analysis of the processes involved, ranging from the warehouses to the laboratories and quality department, as well as the systems in place. We then developed a compelling business case for the client and effectively presented it to top management. As a result, the implementation was approved and given the green light.
Throughout the process, our team provided comprehensive support to the customer, easing their burden at every level. Our skilled consultants drafted user requirements, closely monitored progress with IT, and oversaw the necessary UAT (User Acceptance Testing) activities. We also provided guidance on change and stakeholder management, including communication about project progress to higher management.
The necessary training was organized for the customer's employees. We also provided extensive documentation to fall back on: new processes were mapped out in detail, and the necessary procedures were adjusted. After go-live, we took care of hypercare, responding quickly to feedback and possible issues.
Result
Moore successfully set up a fully automated Quality Control process ac-cording to the customer's wishes. Automation and digital integration were realized without extensive development or customization. A revision of the master data and the accompanying rollout of data governance ensured a reliable and workable basic process. Thorough preparation and structured implementation ensured a successful cutoff and go-live of the new functionality and interfaces. The digital transformation has ensured that the paper process is a thing of the past. Because the automated process now runs much smoother, compliance has increased, and the workload for employees is much lower.
Moore Expertise
The Moore Supply Chain team specializes in improving and digitalizing the Logistics, Planning, and Procurement process domains. Count on us for in-depth analysis and advice on implementation guidance and training for your people.
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