We help optimize processes, ensure compliance, and promote innovation
Optimize Your Business
Create Clarity and Security in a Regulated Industry
Producing medical devices requires more than just precision—it requires adherence to strict regulations and standards such as ISO 13485 and GMP (Good Manufacturing Practices). Our solutions provide you with full traceability in the value chain, control over processes, and ensure compliance with GxP and FDA requirements, MDR (Medical Device Regulation), and UDI (Unique Device Identification). This helps you ensure both patient safety and product quality while navigating complex regulations. With our tailored IT solutions, you can focus on innovation and growth while we efficiently manage your compliance and quality management.
Our Solution
Tailored ERP Solutions that Optimize Your Quality Management
We offer ERP solutions specifically designed for the pharma and medical industries that integrate with your existing Quality Management System (QMS) and ensure compliance with both ISO 13485 and GMP. With Microsoft Dynamics 365 Business Central, you can automate your quality processes, reducing the risk of human error and improving overall traceability throughout the production and distribution chain. Our solution gives you full control over the lifecycle of your medical devices (ALM), from design and production to distribution and support. You achieve efficiency that not only meets today’s requirements but also future-proofs your processes.
Precision throughout Production
Maximum Traceability and Quality Control
Precision and traceability are critical in the production of medical devices, and with our solution, you can easily keep track of all critical processes—from purchasing raw materials to delivering the finished product. Our ERP solutions automate documentation, inspection reports, and quality control, minimizing manual work and ensuring that all products meet the industry’s strict requirements. With Business Central, you not only get a system that ensures compliance but also a platform that optimizes the supply chain and inventory management. You gain an overview of production needs, the ability to track expiration dates on critical components, and can automate both purchasing and logistics. This helps reduce waste, increase efficiency, and adapt quickly to changes in market or production demands.
Industry Challenges
Validation
In a regulated industry, there are requirements for the validation of current software versions, as well as documentation in SOP and Master Validation Plan. MDC Nordic can help minimize or completely exempt customers from these validation requirements in the ERP solution.
If validation is needed, our delivery model ensures documentation and traceability, and we can assist with automated testing for continuous validation.
Quality and Traceability
Quality assurance and traceability in the supply chain are crucial in the Pharma and Medical industries, where mistakes can have serious consequences. Microsoft D365 gives you full control over the supply chain, from raw materials to finished products, ensuring that quality and traceability are maintained at every stage.
RD and Innovation
Research and development drive innovation in Pharma and Medical. With Microsoft D365, we can help streamline your RD processes, integrate data across departments, and support faster time-to-market for new products, all while maintaining high-quality standards.
Data Management
Effective data management is key to making informed decisions. With Business Central and Power BI, we can help you centralize your data, ensure access control, and facilitate analysis and reporting across the organization, giving you the insights you need to act quickly and accurately.
Customization and future-proofing
Easy Integration and Flexibility
Business Central can be easily integrated with existing systems such as Power Platform and Dynamics 365 Sales (CRM), which allows you to create custom applications and analyze data more efficiently. These integrations give you a 360-degree overview of both your processes and customer relationships, making it easier to deliver a personal and efficient service. At the same time, with Azure DevOps you can plan, develop, test, deploy and monitor projects. This will allow you to document risks, ensure traceability in the development process and create an audit trail, which is important for maintaining compliance with regulations such as ISO 13485 and GMP, as well as GxP and FDA requirements, MDR and UDI. At the same time, you future-proof your business in an industry where changes in regulations and market requirements are a constant challenge. With our solution, you are in a strong position – both now and in the future.
Whitepaper
Tag din pharma-produktion til det næste niveau
Download vores eksklusive whitepaper nu.
- Opdag, hvordan MDC Nordic’s løsninger kan transformere din virksomhed.
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