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

Syngistix for AA Enhanced Security™ Software is an extension of Syngistix for AA Software for PinAAcle™ atomic absorption 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 AA 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, password-protected access control, multilevel user permissions, electronic signatures, data integrity, and database file structure.

Part Number N1010314
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Detail Information

And not only does Syngistix for AA 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 AA 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
Technology Type Atomic Absorption
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FAQ

Syngistix for AA 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 AA Enhanced Security™ software for PinAAcle™ AA spectrometers provide 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.

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