Benefits
Benefits Of Solumina For Medical Devices
The Solumina platform provides an innovative approach to simplifying how complex manufacturing, quality, and MRO processes are managed and improved to accelerate Industry 4.0 and Smart Manufacturing strategies.
Ensure Compliance
Meet regulatory requirements and standards including FDA’s 21 CFR Part 11 and CFR 820, ISO 13485, and ISO 9001.
eDHR
Electronic Device History Records are consolidated and automatically update from design through production.
Built-in Quality
Quality management is embedded in Solumina, letting you hard-wire quality procedures into your production process.
Full Traceability
Gain control & visibility over lot and serial tracked parts for all materials, components, and subassemblies from cradle to grave.
Error Reduction
Improve quality with standard work instruction illustrations, 3D-models, videos, slideshows, and built-in data collections.
Auditing & Reporting
Meet reporting requirements easily and generate audits to ensure compliance with internal and external standards.
User Stories
Additional Resources
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