MES for Medical Devices and Diagnostics | Manufacture with 100% US FDA 21 CFR part 11 compliance | Electronic Device History Record (eDHR)
Certification requirements from the U.S. Food and Drug Administration are constantly changing, meaning medical device and diagnostics corporations must continuously reconfigure their business standards to meet those needs.
Atachi offers a cloud-based solution, NGIMES, that helps businesses within the MD&D industry configure their systems while simultaneously reducing costs. NGIMES quickly sets up processes to meet specific FDA requirements, while also obtaining electronic signatures and batch records for your company to process. Auditing is simplified in the cloud, which speeds up otherwise tedious and complex tasks.
Take Control of your Business
Being on the cloud allows medical device and diagnostic companies to complete more work. NGIMES enables paperless manufacturing, as every piece of information is stored in memory. Business leaders achieve complete visibility and control across varying manufacturing locations at any time, and can monitor productivity from any device with Web access. BI data can be accessed instantaneously, so managers are armed with real-time data, optimizing the decision-making process.
With no on-site IT maintenance needed, your company can lower personnel costs while improving productivity.
NGIMES is easy to set up and can be completely modified to fit your business’ specific needs.
NGIMES enables paperless manufacturing to optimize process control. Managers have complete shop floor visibility across manufacturing sites at any time from any device. Instant access to BI data ensures timely and accurate decision-making.
What You Get
US FDA 21 CFR Part 11 regulatory compliance
electronic signature and device history record (eDHR)
High-performance process control
Paperless manufacturing processes
100% real time shop floor visibility
Real-time business intelligence and analytics
How You Benefit
Significant infrastructure cost savings
Minimized product recalls
Reduced need for IT maintenance expertise
Improved process and productivity quality
Fewer barriers to ROI
Reduced time to market
More compliance with US FDA
Lesser/Minimal/ZERO 483 Warning Letters from FDA
Atachi Systems provides manufacturing companies with a seamless, cloud-based Manufacturing Execution System – NGIMES.