ERP for Medical Device Manufacturers
To say that the medical device industry is going through challenges in today’s business climate is an understatement. Regulatory compliance, tough quality control requirements, the complexity of modern medical equipment and the ever-increasing expenses of research and development are all daily revenue and profitability burdens to be faced and addressed. The good news? Epicor has software solutions to address all of these challenges.
Epicor ERP: The Ultimate Medical Device ERP Software
In such a heavily regulated industry, compliance is not just something expected by the government, but something demanded by consumers, as well. You’re dealing with regulations both on a local scale as well as a global one. Epicor’s ERP for Medical
Device Manufacturers enables you to automate your compliance processes for industry and location-specific regulations in order to avoid warnings, recalls, the potential for litigation, steep regulatory fines and dissatisfied customers. You have the audit trails
available to streamline the investigation and resolution of non-conformance issues.
Some of the industry-specific regulations that the ERP addresses:
- Current Good Manufacturing Practice (CGMP)
- ISO 13485 and 9001 standards
- 21 CFR Part 11 regarding secure electronic signature and document controls
Improves Quality Control
A big part of the regulations that have been put forth in this industry pertain to the quality of the product. In truth, providing your customers with the highest quality products available is the foundation of why you do what you do. Unfortunately, you can’t control the quality of something unless you can see all of the pieces that make up the entire experience. This software provides you the visibility you need to ensure the quality of your product from engineering to submission to production to order fulfillment and delivery.
Epicor’s ERP for medical device manufacturers supports traceability in a number of ways, including:
- Reduce time, cost, and the risk of error with paperless tracking
- Lot and serial number traceability
- Serial genealogy of component products to meet customer and industry needs
- Product documentation
- Revision change control
- Electronic signature
- Tracking the movement of materials and parts
- A complete device history record
Improves Sales and Customer Service
Medical device manufacturing ERP provided by Epicor integrates with your Customer Relationship Management software. This helps you enhance your customer service through improved sales pipeline visibility and opportunity management. Being able to track the progress of the production process and all of the materials and parts required for it gives you have the visibility and in turn, the knowledge to streamline your pipeline save on costs.
Improve Your Research and Development Processes
The costs of research and development are often one of the deciding factors as to whether to go forward with a new product. Epicor’s ERP for Medical Device Manufacturers allows you to track those costs and analyze them, as well as to control design and release processes and manage the authorizations required by your engineers.
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