What is the difference between configuration change and validated workflow change?

Why

Consider adding a new sample status to a LIMS dropdown. Technically it may be configuration, but if it changes when results can be released or how unsuitable samples are rejected, it changes a controlled workflow. Trace the requirement to affected user roles, interfaces, historical records and reports.

Decide the appropriate validation effort from patient or product risk, not whether the change required new code. Compare a low-risk display colour update with a new rule that bypasses second-person review. The latter needs evidence that approvals and segregation of duties remain effective.

Document change control, regression tests, permissions, training and rollback, and where applicable obtain quality approval before release. Avoid describing every configuration change as automatically subject to one fixed regulatory test script. Intended use and governing procedures decide the required scope.