New electronic signature capabilities have been added to the vendor’s Simatic Batch software to help users comply with the FDA requirements of 21 CFR Part 11, Electronic Records: Electronic Signatures.
Simatic Batch is the standard batch management software package used with the vendor’s Simatic PCS 7 process control system. It automatically records all operator actions, electronic signatures and events associated with a batch. The new electronic signature capability allows users the flexibility to define multiple signatures to each operator action or batch event, as well as the specific signing order. Simatic Batch electronic signatures leverage security features, including password aging and user ID uniqueness.
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