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

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 laboratories, such as those needing to comply with the U.S. FDA’s 21 CFR Part 11 regulations. Syngistix for ICP Enhanced Security Software (version 4.0 or higher) provides the functionality to fully meet the technical requirements for 21 CFR Part 11 compliance. Key features include: secure audit trail, electronic signatures and records, data integrity, password-protected database file structure, login history, configurable password control.

Part Number N0780214
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Overview

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.

Specifications

Product Group Software and Informatics
Resources, Events & More
  • All

Application Note

Analysis of Allergy Medications Using ICP-OES Following USP 232/233 Guidelines with Software Designed to Aid in 21 CFR Part 11 Compliance

This work demonstrates the ability of the Avio 500 ICP-OES to meet the USP <232>/<233> criteria for the analysis of orally-administered allergy tablets using Syngistix for ICP Enhanced Security software version 4.0, which provides the tools to help laboratories meet 21 CFR Part 11 compliance.

PDF 1 MB
Analysis of SiO2- and TiO2-Containing Medications Using ICP-OES Following USP 232/233 Guidelines with Software Designed to Aid in 21 CFR Part 11 Compliance

This work demonstrates the ability of the Avio 200 ICP-OES to meet the USP <232>/<233> criteria for Class 1 and 2A elements in tablets containing TiO2 or SiO2 as excipients using Syngistix for ICP Enhanced Security software version 4.0 for 21 CFR Part 11 compliance.

PDF 1 MB

FAQ

Syngistix for ICP Enhanced Security Software for Laboratories Subject to 21 CFR Part 11 Regulations

The regulations of 21 CFR Part 11 cover overall system compliance and include administrative, procedural and technical elements. Software alone cannot be compliant without the development and implementation of the other elements. PerkinElmer’s Syngistix™ for ICP Enhanced Security™ software for Avio® and Optima® ICP-OES systems provides features that, when coupled with appropriate policies and procedure, fulfill the requirements for closed-system electronic records in 21 CFR Part 11. Syngistix Enhanced Security software also fulfills the elements relating to electronic signatures.

PDF 221 KB