Change Requests, CAPAs, Anomalies, and Complaints are included in the Change Management File (CMF) only when they affect or are related to any items that change within the current release. If they are not affected or are not related to any item change, then they won’t be included.

For point-wise items like Change Requests and CAPAs, this means they appear only in the version specified in their "Introduced in Version" field. In contrast, long-lived items like Anomalies and Complaints span multiple versions: they appear in every CMF from their "Introduced in Version" until (but not including) their "Obsolete in Version." For example, an Anomaly introduced in 1.0.0 will be included in the CMF for all subsequent versions it remains active in, and may be pulled into a later release (e.g., 1.0.2) if newly linked items are impacted. Record locking can override this logic, and the type of release (full, patch, or scoped) can also influence inclusion. This behavior is defined in the Ketryx Lifecycle Management Manual (MAN-01).