GOT2000 and GOT1000 Series FDA 21 CFR Part 11 Compliance Technical Bulletin
This technical bulletin provides instructions for constructing a system using Mitsubishi Electric GOT2000 and GOT1000 series terminals that complies with FDA 21 CFR Part 11 regulations for electronic records and signatures. It details how GOT functions support specific regulatory requirements such as user authentication, audit trails, data security, and validation, while also noting restrictions and user responsibilities for system construction and operation.
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