The CTS Rotea instrument itself is not 21 CFR Part 11-compliant as it does not store any data that requires the compliance. To enable customers seeking 21 CFR Part 11 compliance, Thermo Fisher Scientific is developing Rotea SAE and Cellmation software options to provide additional security, auditing, and e-signature functionality. Additionally, the CTS Rotea System can be connected to a Laboratory Information Management System (LIMS) or Manufacturing Execution System (MES) via an OPC-UA interface to meet customers' site needs.
Answer Id: E18776
Yes
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