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TMF Inspection Readiness: How a Mindset of Readiness Builds a Culture of Compliance

For many organizations conducting clinical trials, regulatoryinspections arefrequently feared and unwanted by clinical teams.Typically,chaired by the Quality Assurance department, TMF inspections bring with them a wealth of administrative tasksand procedural checklists to the table. In many instances, an inspectionbecomes a tedious exercise. The recurring problemis that inspection readiness is typically performed as a preparatory activity, whereas the most value is generated wheninspection readiness is engrained into your organization from the start and daily maintenance is simply apart of the culture.