FDA 21 CFR 11 Compliance Software
GENESIS32 makes it easy to create applications that comply with the latest FDA regulations. Audit trails, enforced logins, and restricted security access are integrated into every GENESIS32 software system. Using the GenEvent Server, a standard part of GENESIS32, keeping track of operator input changes is automatic. This tracking system records the date and time stamp along with the name of the person performing the action, as well as the value entered and the tag name being affected. In addition, GENESIS32 also captures the node name, thus recording information pertaining to who, what, when and where.