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FAQ

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

Introduction

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.