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Corrective Actions Report

Lists all the corrective actions (both approved and unapproved) for each system, and provides a summary of the time and cost estimates. This report can also be run for all systems so that you can get a good idea of the total time and cost for the entire remediation program.

The Corrective Actions Report lists corrective actions and provides a summary of time and cost estimates

Additional Information

Part 11 Advisor - Assess your compliance with 21 CFR 11.

Part 11 Assessments - Ofni Systems can assess all of your systems for compliance with 21 CFR 11.

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CDER indicating increased inspections for compliance with 21 CFR 11