Exalta

Exalta

Exalta

Product catalog summary
Introduction
Exalta is a smart device designed for traceable microscopy, enhancing the quality control process in medical device manufacturing. It ensures consistent evaluation of defects like chips and scratches, crucial for meeting quality standards.
Key Features
  • Reliable Inspection: Exalta allows for consistent inspections across multiple operators by providing step-by-step work instructions, aiding in uniform pass/fail decisions.
  • Report Generation: The device facilitates efficient and robust report generation, minimizing manual errors through an automated digital approval workflow.
  • Compliance: Exalta is prepared for compliance with 21 CFR Part 11 and GxP, ensuring the validity and traceability of digital workflows, reports, and data files.
Configurations
  • Standard Configuration: Suitable for operators working less than 2 hours continuously with the microscope.
  • Ergo Configuration: Designed for operators engaged in more than 2 hours of continuous work, requiring intense concentration.
Connectivity and Integration
Exalta can be integrated into existing IT infrastructures, enhancing inspection capabilities through network connectivity. This integration supports the distribution of procedure revisions, report leveraging, and secure centralized data storage.
Conclusion
Exalta offers a comprehensive solution for traceable microscopy, improving the reliability and efficiency of quality control processes in medical device manufacturing.
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Catalog excerpts

Exalta-1

LEVEL UP YOUR QUALITY Exalta - Your smart device for traceable microscopy Visual inspection with a microscope is a big part of your medical device quality control. Consistent evaluation of defects, such as chips and scratches, is critical to meet the quality requirements. Compliance with standard procedures across multiple users ensures consistency of results. Achieving these goals also requires efficient adaptation and implementation of changes to procedures. Exalta is a smart device for traceable microscopy that helps you deliver reliable quality results. With Exalta, you can: > Inspect reliably across multiple operators > Generate robust reports efficiently > Be ready for 21 CFR Part 11 and GxP

 Open the catalog to page 1
Exalta-2

Inspect reliably across multiple operators Generate robust reports efficiently Guide operators with step-by-step work instructions and help them make consistent pass / fail decisions. Reduce manual steps and sources of error during automated report generation and handling with a digital approval workflow. Example: Quick go / no-go decisions with overlay comparisons. Diagram showing the role of users regarding a digital approval workflow. Be ready for 21 CFR Part 11 and GxP Check the validity of digital workflows, reports, data files, and signatures with full traceability back to individual users....

 Open the catalog to page 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.