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Syngistix for ICP Enhanced Security Software for 21 CFR Part 11 Compliance

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Syngistix™ for ICP Enhanced Security™ Software is an extension of Syngistix for ICP Software for Avio® and Optima® ICP-OES spectrometers, delivering additional capabilities needed by highly regulated ......

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And not only does Syngistix for ICP Enhanced Security software provide the required functionality to aid in compliance with 21 CFR Part 11, it does so simply:

  • Administrators define users & groups, set up permissions, electronic signatures, and security settings – and much more under User Setup, a simple but powerful app outside of the main Syngistix operating environment.
  • Once user permissions and e-signature parameters are set and samples are ready, the operator can perform analyses within the limitations defined by the Administrator in User Setup, guaranteeing traceability with a secure audit trail and data integrity.
  • After an analysis is complete, the data can be quickly reviewed and approved/rejected through ES Tools – this dashboard interface lets you quickly and easily review data, methods, the audit trail, event logs, and file changes.

Syngistix for ICP Enhanced Security software version 4.0 provides regulated laboratories powerful but simple-to-use tools to meet the technical requirements for 21 CFR Part 11 compliance, offering flexibility while providing electronic signature points, maintaining data integrity through a database file structure, and implementing a secure audit trail.

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