Keep evidence and generated documents aligned

Generated documents depend on the evidence and facts available at generation time. If you replace an IFU, add new clinical data, change material information, or update a risk control, previously drafted documents may become stale.

Review stale warnings before delivery. A small source edit may not affect every document, but classification, clinical, risk, labelling, and PMS changes often have cross-document impact.

When unsure, ask your expert whether the change is editorial, evidence-bearing, or regulatory-significant. That distinction determines whether a simple note is enough or whether documents should be regenerated and reissued.