Oxaion and Oxaion easy: The business software
for medical technology – UDI Ready
With oxaion's medical technology software, regulatory requirements can be better met in the future when companies optimize and digitize their processes.
We have consistently tailored our ERP software for medical technology to the needs and guidelines of the medical technology industry and have already implemented many aspects that an ERP system for medical technology will have to cover in this field of application in the future:
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Integrated DMS and project management
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User authorization concept
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Audit trail (complete tracking of changes)
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Dual control principle for GxP-critical processes
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Management and tracking of batch and serial numbers
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Electronic signature
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UDI creation (Unique Device Identification) including EUDAMED data (ERP software for UDI in medical technology)
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Compliance with GAMP 5 requirements for the validation of computer systems
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Quality control
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Quality management including CAPA
The medical technology software oxaion and oxaion easy ERP (the version for smaller medical technology companies) fully meet these functional requirements.
In addition, the software solutions offer modern standard technology for seamless interaction with other systems and platforms, as well as maximum flexibility when you need to adapt quickly to changing conditions. This means that all UDI data required for EUDAMED can already be maintained in oxaion today.
Batch/SN tracking result file
For smaller
medical technology companies
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Medical technology software: The preconfigured, fully validatable standard solution oxaion easy includes all of oxaion's core functionality.
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Additional functions for document management, analysis, and dashboard configuration significantly reduce the effort required for (validation) documentation and specification creation.
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As an ERP software provider for medical technology, we have numerous references and offer our customers unique identification of medical devices and their packaging (UDI / Unique Device Identification for medical devices).
Our medical technology
network
oxaion ERP software in medical
technology
The areas mentioned are specifically tailored to the requirements of your industry. In addition, oxaion offers many other comprehensive and additional functions.
