Digital Excellence in the Pharmaceutical Industry- Introduction of Microsoft Dynamics 365 Supply Chain Management
- Validation of the D365 solution in accordance with the requirements of EU-GMP Annex 11, FDA 21 CFR Part 11, and others in accordance with GAMP 5 Second Edition
Formycon and Sycor set new standards for
validated ERP processes
Validated Supply Chain Processes with Microsoft Dynamics 365
Formycon AG, a leading developer of biopharmaceutical follow-on products (biosimilars), faced a pivotal moment at the beginning of 2025: Following the approval of two biosimilars and in anticipation of their planned market launches , it became clear that a validated, regulatory-compliant ERP solution for supply chain management was essential. Until then, no such solution existed within the company—posing the challenge of rapidly establishing a digital infrastructure that meets the highest regulatory standards while laying the foundation for future growth.
Targeted Implementation Under High Time Pressure
The project goal was clearly defined: to implement a standard-oriented ERP solution based on Microsoft Dynamics 365 for procurement, warehousing, production, and distribution of the approved drugs. A “fit-to-standard” approach was chosen to ensure efficient and future-proof processes. Sycor was responsible for implementing Dynamics 365 Supply Chain Management (SCM) and conducting full computer software validation in accordance with GAMP 5 (GxP-compliant). A Minimum Viable Product (MVP) was developed that met all regulatory requirements while digitizing core business processes.
Industry Expertise and Unique Selling Proposition:
Why Sycor for Pharma/Biotech?
Sycor is ideally suited for the pharmaceutical and biotech sectors, thanks to its profound expertise in regulatory requirements such as EU-GMP, FDA 21 CFR Part 11, and GAMP 5. Its extensive experience with GxP projects and ability to translate regulatory complexity into efficient digital processes make Sycor a trusted partner.
Kristina Gehrke, Project Manager at Sycor, highlights:
"In the pharmaceutical industry, it is crucial that quality, compliance, and speed are not mutually exclusive. Our industry expertise and customer focus are the keys to success.”
Methodological Expertise and Validation Know-How
Sycor applied a fit-to-standard approach to ensure standardized processes for maximum efficiency. The MVP strategy enabled a fast yet regulatory-compliant solution. Agile project management allowed for flexible adaptation to new requirements and close coordination with the client.
A particular challenge was the software validation, which was conducted in parallel with the implementation and was a prerequisite for go-live. With the support of a partner for computer software validation, the validation was completed fully and on schedule. All relevant documentation, test plans, and final reports were created in accordance with regulatory standards.
Sustainable Process Optimization
The implementation of Dynamics 365 enabled Formycon to structure and digitize key processes—from material requirements planning and production control to quality assurance and sales. The solution now supports the entire product lifecycle management for both end products and their components, ensuring transparency and efficiency across the complex international supply chain.
Ivan Avila adds: "With Dynamics 365, we now have a solution that not only reflects our processes but actively supports them—in an environment where quality and traceability are top priorities."
Sales Perspective and Partnership
Formycon chose Sycor for its suitable resources, industry expertise, and methodological competence in project management. The successful implementation, standard-oriented approach, and first-time validation make this project a true highlight—for both Formycon and Sycor.
Carsten Werner, Sales Expert at Sycor, emphasizes: "Our clients in the pharmaceutical industry expect not only technological expertise but also a deep understanding of their regulatory challenges. That’s exactly what we offer—and we deliver it through collaborative partnership."
Customer Value
The validated implementation of Microsoft Dynamics 365 meets all requirements for the approval and commercialization of drugs in a highly regulated pharmaceutical environment. Standard-oriented processes ensure efficient operations across the entire supply chain—from procurement to sales. The solution is scalable and optimally supports future growth and additional product approvals.
About the company
Company name: Formycon AG
Headquarters: Martinsried-Planegg near Munich, Germany
Industry: Biopharmaceutical drugs (biosimilars)
Website: https://www.formycon.com/
Project & Services
- Introduction of Microsoft Dynamics 365 Supply Chain Management
- Validation of the D365 solution in accordance with the requirements of EU-GMP Annex 11, FDA 21 CFR Part 11, and others in accordance with GAMP 5 Second Edition
- Project management for ERP implementation and validation
Benefits
- The validated implementation of Microsoft Dynamics 365 meets all requirements for the approval and marketing of drugs in the highly regulated pharmaceutical environment.
- Standardized processes ensure efficient workflows along the entire supply chain – from procurement to sales.
- Thanks to close project management and the MVP approach, go-live was achieved within just seven months of project duration, including all phases – a decisive factor for the timely product launch.
- A scalable solution that optimally supports future growth and further product approvals.
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