Regulated Industries Success: Biotech Industry Leader Achieves Remarkable Growth and Efficiency Through Digital Transformation

A biotech industry frontrunner successfully navigates rapid growth and operational complexity by leveraging Microsoft Dynamics 365 and Merit for Life Science in a transformative digital journey.

About

A global leader in the development and delivery of GMP and research grade plasmid DNA, proteins, enzymes, and other biologicals embarked on a digital transformation journey to achieve its strategic goals for growth and operational efficiency. Transitioning from NetSuite to Merit for Life Science and Microsoft Dynamics 365, this biotech industry pioneer sought a secure, compliant ERP cloud solution tailored to the unique demands of the biotechnology sector.

Their vision encompassed bolstering operational efficiency and accommodating their exponential growth trajectory. By executing this transformation, they now run 24x7 manufacturing operations with heightened capabilities for managing quality, compliance requirements, and efficiency metrics across all departments.

Challenge

The customer, operating within the dynamic realm of biotech manufacturing, faced challenges stemming from their rapid growth. Their existing systems, including NetSuite and homegrown solutions, struggled to keep pace with their intricate requirements. Serving a diverse clientele, from emerging companies relying on R&D-grade products to supplying GMP materials to some of the world's largest organizations, presented a complex landscape. Collaboration with customers on drug and therapy production, ensuring both quantity and quality met commitments, was crucial.

Solution

To address these challenges, the customer turned to Microsoft Dynamics 365 and Merit for Life Science. This strategic partnership provided a commercially available, change-controllable solution. It replaced their heavily customized systems, resulting in improvements across critical quality processes, flexible sampling and frequency rules, stability and re-test quality testing, and enhanced materials control for sub-batching support. The implementation also streamlined material requirements planning (MRP) and resource scheduling. Access to well-organized, transparent reporting facilitated data capture and validation, a critical requirement for FDA and customer audits. Furthermore, the ERP solution offered robust financial management functionality to support tracking of multiple legal entities and ensure Sarbanes-Oxley compliance. Enhanced data management capabilities enabled cost control in their rapidly expanding business.

Results

The adoption of Microsoft Dynamics 365 and Merit for Life Science yielded impressive results. Key metrics for capacity utilization, trends in scrapped lots, turnaround times at various stages, financial performance indicators (such as profit, revenue per customer, production costing, and inventory costs), customization flexibility, and process efficiency were successfully met. Inventory accuracy surged from sub-60% to over 90%, drastically reducing order delivery commitment times from six months to just 90 days. Additionally, financial period closing time was dramatically reduced from 21 days to a mere three days.

Much of the credit for this successful implementation goes to a dedicated executive steering committee that established clear post-implementation metrics. Department leaders collaborated through an Envisioning Workshop to align processes with strategic growth objectives. This workshop produced actionable insights on how to collaborate effectively to achieve their business goals. Remarkably, even amidst rapid growth, the organization stepped up as a pivotal mRNA manufacturer during the pandemic while continuing to serve customers whose therapies save lives every day.

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