FEATURES:
- Ensure compliance with 21 CFR Part 11, 21 CFR Part 210, 211, and ISO standards
- Implement a closed-loop quality system consistent with FDA thinking and industry best practices
- Implement best-of-breed quality management while integrating to ERP and MES systems
- Maintain high quality levels while conducting manufacturing operations across outsourced sites and supply chain partners
- Reduce costs incurred by re-works, scrap, and process down times
- Increase product quality and support efforts to enhance brand equity
- Reduce cycle time and increase time to market
- Adapt quickly to manufacturing changes and reduce time-to-market
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