Manufacturers face stringent regulatory requirements including standards like ISO13485 and FDA 21 CFR Part 820 and Part 11 for quality management and electronic signatures.
Eyelit Technologies’ MES, QMS, and APS solutions offer medical device manufacturers the tools they need to meet these stringent requirements while ensuring efficiency and quality.
Differentiating capabilities
and Genealogy
Provides end-to-end traceability, documenting every stage of the production process, from design to finished product, ensuring all regulatory requirements are met.
Factory
Automatic collection of electronic device history records (eDHR) provides an immutable audit trail of quality records on a foundation of blockchain technology.
Non-Conformance Management
NCR and CAPA Management. Enforces robust quality processes and version controls, ensuring that products meet strict quality standards and regulatory guidelines.
Compliance
Helping manufacturers adhere to FDA regulations and ISO standards, ensuring compliance with CGMP, 21 CFR 820, and Part 11 for electronic records and signatures.
Monitoring
Offers real-time oversight of production and quality metrics, enabling quick identification and resolution of any potential issues or defects.
Control
Ensures consistent adherence to Current Good Manufacturing Practices (CGMPs) with enforced process controls, reducing the risk of non-compliance or product recalls.
and Prevention
Identifies suspect materials and product defects early in the production cycle, preventing faulty products from reaching the market and ensuring patient safety.
Control
Configurable approval process allows robust revision control where required but allows streamlined administration where changes do not impact quality.
Production Planning - Keeping Promises
A global manufacturer, with a strong brand and reputation for producing quality high-value products, started losing market share. The operations teams quickly discovered that customers
were leaving because they could no longer depend on the timely delivery of the manufactured goods. The delivery date provided by the manufacturer was often inaccurate by as many as several weeks.
Composable APS & MES solution stack optimizes smart factory operations
The Composable Smart Factory Solution Stack which combines planning, scheduling, order management, sequencing, dispatching and execution is a foundational set of apps, modules, and solvers that make it easy to deploy a smart manufacturing solution within and across your factories.
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