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Proactively finding and correcting production problems is critical to manufacturing efficiency and the bottom line. eyelit Quality™ delivers the ability to automatically find, track and resolve quality and compliance issues from initial detection through corrective and preventive action across the enterprise. And because the system is close-looped, you know when products are perfect and in compliance, and production is working the way it should.

Eyelit Quality™ provides integrated out-of-the-box
paperless capability for:
  • Real-time Statistical Process Control (SPC)
  • Corrective and Preventive Actions (CAPA, OCAP, CAP) Management
  • 21 CFR Part 11 and Other Regulatory Compliance
  • Non-conformance (Deviation) Tracking and Disposition
  • Customer Relationship Management (CRM)
  • Supplier Relationship Management (SRM)
  • Audit Management
  • Quality Data Collection, Repository & Analysis
  • RMA Management
  • Operator Certification
  • Sampling Plans

No matter how complex the product or process, eyelit Quality™ delivers remarkably flexible and easy-to-use tools for increasing quality, continuous improvement and reducing unwarranted costs. It eliminates quality related errors as product moves through production by continuously monitoring/searching for non-conformance, analyzing the problem, alerting the proper parties or systems, and taking action to resolve issues. The system is seamlessly integrated with eyelit Manufacturing™, and other enterprise systems for providing accurate electronic device history records (eDHR). It monitors at the finest levels of detail to catch the smallest defects on the floor and remedy them before they become costly problems or product recalls. eyelit Quality™ enables true continuous process improvement by following issues to their root cause and electronically managing CAPA processes to fix and prevent problems in the future. So enterprise quality is always under control.
 
 
QUALITY MANAGEMENT YOU CAN COUNT ON

Turning Quality Data into Quality Intelligence
The system performs multi-dimensional data collection at the lot, product, part or material level. It creates a central repository for all operational quality data so that no quality detail is lost. Analysis can be performed at data collection (as with real-time SPC), before, or after storing for fast issue detection or long-term trend analysis. As with all Eyelit products, eyelit Quality™ stores data in an open format that can be easily analyzed by eyelit Intelligence™ or any open database tool.
 
Now Quality Issues Have Nowhere to Hide
eyelit Quality™ creates a paperless quality management system that extends to every corner of the business—even across facilities. With seamless integration to production and business systems, eyelit Quality™ can continuously find and take action to resolve issues before they can become quality problems no matter where they may hide.
 
Getting to the Root and Closing the Loop
eyelit Quality™ delivers unparalleled capabilities for recording, routing, managing, and resolving the root cause of quality complaints, deviations, or non-conformance.

The system electronically manages all steps in the process:
  • Generate Corrective Actions and track them through to completion
  • Classify issues easily and consistently
  • Associate multiple lots, products, parts, materials, manufacturing sites, vendors, or classifications to each issue
  • Assign and track action items for each activity and role
  • Hold and release manufacturing materials or auto-generate NCR via real-time integration with MES
  • Recall product via link to MES historical data (lot numbers, serial numbers, materials, parts, or products)
  • Control and verify the entire process with 21 CFR Part 11 regulation and guidance on compliant electronic records, approvals, and signatures
 
Get Ahead of Trends and a Handle on Audits
With eyelit Quality™ you get a clear picture of trends before they become non-conformance or customer complaints. Manage internal and external audits efficiently and securely with electronic scheduling, approvals, and signatures. Document findings and actions directly to the issue record to ensure data integrity. Full integration with the QMS module means seamless corrective action follow-up.
 
QUALITY MODULES

  • QMS
    Automatically detect, analyze, and resolve quality deviations, non-conformance, incidents, or complaints in every corner of the business. A comprehensive closed-loop application seamlessly interacting with other quality and enterprise systems means quality issues are proactively found and resolved before they become profit-eating problems.
  • SPC
    Continuously and automatically perform statistical analysis against production data collected in real time for instant detection and notification of production problems.
  • Subscription Messaging
    Enable users to select notification of alerts/events most important to them, so each can stay on top of his/her own critical issues.
 
 
"Eyelit is one of a new breed of production management suppliers that "gets it" when it comes to plant software. This is what manufacturers need in order to enhance enterprise performance in real time."