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.
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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:
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.
|Product Group||Software and Informatics|
With the implementation of USP <232>/<233> for the analysis of elemental impurities in finished drug products, it is important for manufacturers to monitor the metal content of the final products to be in compliance. This work demonstrates the ability of PerkinElmer’s Avio® 550 Max fully simultaneous ICP-OES to pass validation testing for Class 1, 2, and 3 elements for USP <232>/<233> methodology, while allowing labs to comply with 21 CFR Part 11.
Since early 2018, manufacturers of pharmaceutical products are mandated to comply with USP <232/<233> requirements around the analysis of elemental impurities in medications. This work demonstrates the ability of PerkinElmer’s Avio® 220 Max hybrid simultaneous ICP-OES to pass validation testing for Class 1 and 2A elements for USP <232>/<233> methodology, while allowing labs to comply with 21 CFR Part 11.
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.