Challenges our ERP For the medical technology Helps to solve
Strict regulations
Medical Device Regulation (MDR), Good Manufacturing Practice (GMP) and more - our ERP for medical technology meets the requirements of the relevant regulations.
Validated ERP
ERP for medical technology is designed for the regulated environment and developed according to GAMP 5. As the solution is considered standard software (GAMP category 4), this reduces the workload for validation.
Increasing demand
With an increasingly aging population, the demand for medical equipment is growing. You can invest the valuable time saved by using our ERP system in new developments.
Audits
Software audits are an important part of the medical device industry - and a challenge. With a validated implementation procedure and transparent processes, audits can be approached calmly.
Trace lots
If a product does not meet your quality standard, you can easily track lots if required—uncomplicated, and with no gaps. For a quick response when you need it.
Check quality
The demands on products in the medical technology industry are particularly high, and the areas of operation are sensitive. With our ERP, you always have an eye on quality control.
Our ERP references in medical technology
The following companies have successfully deployed our ERP for medical technology.
Menicon
„In addition, we wanted our ERP partner to be a well-established company with adequate resources and a significant number of available consultants. This provides cover for vacation periods or in the event of illness."Michael Bachmann Read more
Bort Medical
„YAVEON works well for many of our customers, and which argument could be better than a personal recommendation?"Samuel Erz Read more
The most important advantages of our ERP system for the medical technology industry
Those who rely on Microsoft ERP can look forward to a very special advantage: intuitive operation. Microsoft Dynamics 365 Business Central and our industry solution YAVEON ProBatch impress with the typical Microsoft look and feel.
Work intuitively with a familiar interface
Our ERP system for medical technology is based on Microsoft Dynamics 365 Business Central. You benefit from a solution in the signature Microsoft design. So much easier, right?
- Perfect for small and mid-sized companies.
- Provides an overview of all relevant business processes
- Automated processes and reduced workload.
- More time to achieve sustainable success and growth
Fulfilled regulations - satisfied inspectors
As you work more transparently, and automated using scanners, you meet the requirements and comply with the strict regulations of the medical technology industry.
- Integration of the logistic scanner processes
- Optimized for cooperation with contract manufacturers
- Choose the most suitable implementation model
Reliable and secure data of the highest quality
The accurate capture and storage of data is a prerequisite for being able to trace and document processes when required. The change controls in the audit trail make this possible. Providing you with peace of mind.
- Compliance with the respective regulations
- Free parameterization of critical data
- Protective mechanisms at field level
- Documentation of changes and the cause
Pass computer system validation audits
To meet computer system validation requirements, GAMP 5 requirements must be met. Our ERP industry solution for medical technology is developed precisely according to these requirements. And what about the specifications of GxP critical processes? Done. Of course.
- Product documentation and validation process templates
- Support of change process and update scenarios
- Adaptation of our system to your validation specifications
- Compliance with GMP requirements with GMP relevant documents
Satisfied customers thanks to maximum quality and security
Maximum security with reduced workload and more transparency right from goods receipt—made possible with quality assurance that meets compliance requirements. Our ERP industry software enables you to meet quality criteria at all times.
- Quality assurance and testing accuracy specifications per product
- Manage test plans and means and create certificates of analysis
- Monitoring of cleanrooms or equipment
- Adherence to Audit Trail, regulations, and compliance.
Respond incredibly fast when required
With a clear overview of your lot status, you can easily trace lots back if necessary. Batch traceability reduces errors, increases safety, and facilitates operation, especially in batch handling—for maximal traceability along your entire supply chain.
- Lot and serial number tracing
- Lot status and characteristics management
- Changes to lot info only by authorized persons
- Splitting and mixing of batches, as well as authorization control
Successful business relationships thanks to highest product quality
Are your suppliers an essential part of your supply chain? Do regulations such as ISO, FDA, or GMP require you to monitor and audit your suppliers? With our ERP for medical technology, you can easily meet these requirements:
- Configurable supplier qualification with hard and soft criteria
- Automated evaluation of schedule and quantity adherence
- Capture of soft criteria for evaluation
- Quality qualification via testing system based on delivered products
Warehouse and logistics management - run smoothly, with a clear overview
If you lose track of your warehouse and logistics management, chaos is sure to follow. It is critical that manufacturing companies stay on top of things. This is how our ERP supports you:
- Separation of storage areas such as BTM or cold storage is possible
- Control station for shipping processing
- Quarantine, restricted, and other batch statuses taken into account
- Extensive availability calculation regarding batch status and rules
Satisfy customers with innovative research
Your goal is to meet customer requirements in the long term. You need to meet expectations while continuing to manufacture at a profit. ERP for medical technology helps:
- Develop and manage recipes/bill of materials for new products
- Version management of your recipes and parts lists
- Selectively release recipes for manufacturing
- Calculate costs of new products directly in the system
Combine our ERP system seamlessly with other solutions
Our ERP system for medical technology is versatile. It becomes even more so if you add other options. The most suitable include:
ESCM to exchange data with partners and suppliers.
DMS to process content and documents transparently and automatically
Analyze data intuitively, correctly, and in a visually appealing manner with Microsoft Power BI.
Microsoft ERP meets ERP industry solution
Are you looking for more in-depth information on our ERP system? You have come to the right place.
In the whitepaper on our ERP system for the medical technology industry, you will learn
Computer system validation in the cloud - is this possible?
Whether to run your ERP system for medical technology on-premises or in the cloud is up to you. However, cloud solutions are increasingly looking like the future, and ever more organizations are opting for this. But is that compatible with validation?
Validated ERP implementation in the private and public cloud
A private cloud fulfills the necessary specifications to implement an ERP system in a validated manner. You or your software provider decide both on access to the data and on updates - and this is where the challenge lies, as updates must be carried out within the scope of the permitted computer system validation. This requires some preparation and individual coordination, some of which is handled by an external inspector. Conclusion: Validation in the public cloud is possible in principle, but under special conditions. Together we will find your way into the cloud!
Why YAVEON
6 locations, more than 750 customers, 200+ employees and a global partner network. Due to years of experience, we stand for maximum quality and satisfied customers.
FAQs: Answers to the most important questions about our medical technology erp
You have questions? We have the answers.
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