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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. |
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QUALITY
MANAGEMENT YOU CAN COUNT ON
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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. |
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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. |
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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
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Get Ahead of Trends and a Handle on Audits |
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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
CAPA module means seamless corrective action follow-up.
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QUALITY MODULES
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-
CAPA
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.
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