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Application Note: Cubis ll MCA 21 CFR Part 11 compliance checklist
6 December 2023

Weighing in a regulated environment can be complex, needing stringent compliance directives and controls to deliver the accuracy and reliability of results required by the pharmaceutical industry. The Cubis® II MCA software allows customers to be fully compliant with 21 CFR Part 11, but compliance can only occur if the QApp package pharma (QP1) is licensed and the applications user management, electronic signature and audit trail are used. In this compliance checklist, Sartorius details how this technology can help users to monitor relevant details of the regulation and help them to meet the regulatory needs of the pharmaceutical industry.