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How Dynamics 365 Business Central reduced the material release process from 30 minutes to 30 seconds in the pharmaceutical industry
Case Study
Client profile
Client Profile
A leading pharmaceutical company in Central Europe specializing in multi-stage drug manufacturing and both domestic and international distribution.
The company operates under strict GMP (Good Manufacturing Practice) standards and serves national pharmacies as well as international markets
Challenges and needs
The company was using a distributed and partially automated IT system, which resulted in the following difficulties:
- Lack of full batch traceability required for GMP audits and inspections.
- Manual cost calculations and dependence on multiple separate Excel spreadsheets.
- Problems integrating multi-stage production, quality control, and warehouse management into one coherent process.
- Increased risk when handling expensive and sensitive raw materials and semi-finished products.
- Growing regulatory requirements, including GMP compliance, made it necessary to implement an integrated and validated ERP system supporting production, quality, and financial processes.
Solution
The implemented solution was based on Microsoft Dynamics 365 Business Central, using its production management, warehouse (WMS), quality control, and external system integration capabilities. The implementation covered several key areas:
Process mapping with GMP compliance in mind
- Each production, quality, warehouse, and financial process was analyzed and documented.
- Dynamics 365 Business Central was implemented, configured, and validated to ensure full GMP compliance.
- Every system change was documented and tested to maintain complete regulatory conformity.
Integration of production, quality, and warehousing
- Multi-stage drug manufacturing with full batch traceability from raw materials to finished products.
- Integration with the LIMS system, raw materials and intermediates are released to production only after laboratory approval.
- Control of expensive and sensitive raw materials and batches, including transport history and storage conditions.
- International sales managed within a single system, invoices and documents available in multiple languages and alphabets (including Cyrillic).
Precise finance and cost control
- Automated allocation of costs and variances to individual products.
- Work-in-progress (WIP) calculation for partially completed production orders.
- Multi-level cost settlements for complex pharmaceutical manufacturing.
- New product cost simulations that account for drug registration, research, material costs, work centers, and overheads, adjusted for planned production volumes.
Security and access control at the pharmaceutical level
- Field- and document status–based permissions with full user activity tracking.
- Two-step approval for critical operations (e.g., batch release authorization).
- Qualified Person (QP) management compliant with GMP requirements — even system administrators could not modify QP login data.
Results of the Dynamics 365 Business Central implementation
- Full GMP traceability from raw materials to finished products, ready for any audit.
- Significant efficiency improvement - the process of releasing materials from the warehouse to production, previously handled through multiple spreadsheets and systems, was reduced to a single confirmation in BC, cutting time from 30 minutes to 30 seconds.
- Automation of financial processes and a major reduction in manual work.
- Efficient handling of domestic and international sales with complete documentation in multiple languages.
- A scalable ERP platform ready for further digitalization and process automation.
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