u/No_Alternative_5699

When a product-related event happens — complaint trend, service issue, labeling concern, software/parameter change, CAPA screening, or risk-file review — where do the related records actually surface?

Do CAPA history, complaint evidence, risk controls, prior similar decisions, and external signals appear in the same review workflow?

Or does someone usually have to reconstruct the evidence manually across QMS, PMS, risk files, emails, spreadsheets, and public databases?

I’m trying to understand whether the real gap is “lack of evidence” or “evidence appears too late at the decision point.”