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Designed to enable 21 CFR Part 11 compliance, providing data integrity across IT systems such as file systems, database systems, laboratory or manufacturing instruments.
We understand the complex, ever-changing regulatory environment and markets with the challenges in healthcare, devices, and research industries to blend our expertise with business acumen to provide innovative and compliant solutions for various maturity levels of your organization.
Generate an audit report based on specific data events, such as data creation, deletion, or modification, and with login/log-out session with duration information.
Configure the meaning of e-signatures for data events through Picklist. This can be monitored through an audit trail to prevent super users (like Admin) from changing the choice of Picklist later.
Compliance Builder manages your quality and compliance processes with full integration of all core business processes including R&D, laboratories, manufacturing, and testing on a single platform.