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


21 CFR Part 11 compliance is mandatory for pharmaceutical companies and their suppliers to sell products into the United States. This regulation puts forward the criteria for electronic records, electronic signatures, and audit trails to ensure data integrity and reliability during the analytical testing. For elemental impurities testing using ICP, 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.