Syngistix™ for ICP-MS Enhanced Security™ Software is an extension of PerkinElmer’s Syngistix for ICP-MS Software and NexION® ICP-MS instruments, 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.
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Supplementing the regular Syngistix for ICP-MS Software package, which already leverages the powerful security features of Microsoft Windows, Syngistix Enhanced Security provides a user-friendly experience with additional functions, such as digital signatures, Master Event Log and File Change Log, helping today's laboratories cope with the regulations mandated by government agencies or quality protocols.
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 NexION® ICP-MS 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.