 SMART - A Quality Execution System
QCR makes an Quality Execution Management Solution called SMART, a robust software product. SMART operates at the market intersection of Business Rules Engine and Business Process Execution per the Gartner Group. A five minute analyst audio summary is available. SMART’s new compliance functionality is in place at an industry leader for mistake-proofing medical device manufacturing. It has been certified to FDA’s 21CFR Part 11 & 820 requirements. SMART provides audit-proof electronic history records (eDHR, eBHR, ePHR), the result of doing it right the first time.
In short, the QCR Execution System measures significant events as they occur throughout your enterprise. These measurements are compared to requirements. When significant variances are detected, the system immediately alerts and may even be configured to assign and require corrective action
Benefits include:
- Omission proofing
- Mistake proofing
- Process measurement
- Data exchange
- Multi-media work instructions
- Validation/Verification
- Associate certification
- Supplier/Associate rating
- Notifications/Alerts
- Accurate real-time status updates
- Scrap/Waste reduction
- Process enforcement
- Controlled routing
- Closed loop corrective action
- Historical configuration records
- Faster throughput
- Reduced cycle time
- Reduction or elimination of non-profitable activities
- Cultivation of a “zero defect” environment
- Executive dashboard
The entire supply chain, including end customers, is given real-time on-line visibility into the manufacturing process., improving efficiency and improving customer satisfaction.
The QCR system is fully compliant with the FDA's 21 CFR Part 11 requirements. Specifically, the system provides:
- Role-based system access
- Secure audit trail
- Password authentication for e-signatures
The QCR system assures that the proper procedures are followed - by the proper person - using the proper tools, then compiles a complete historical record, including electronic signatures, for verification/validation.
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