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.

What You Get

  • US FDA 21 CFR Part 11 regulatory compliance
  • electronic signature and device history record (eDHR)
  • High-performance process control
  • Higher yields
  • 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
  • Improved efficiencies
  • Reduced time to market
  • More compliance with US FDA
  • Lesser/Minimal/ZERO 483 Warning Letters from FDA

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