Understand evidence tags
A tag says what kind of evidence a document appears to be — a proposed relationship to processes, never acceptance.
Where to find it
Quality system → Quality evidenceYou need
- A quality document in Your quality documents, read by Complya.
Open a document under Your quality documents. Its detail shows how it was read ("Read", "Still reading", "Read · details needed", "Could not be read"), its control identity and revision, and its evidence tags — the kind of evidence it appears to be, such as a quality manual, a risk-management procedure or an audit procedure. A document with no tag reads "Not yet tagged as evidence" and no process can rely on it.
Read documents proposes tags from the document's content; accept or dismiss each suggestion, or add a tag yourself. The processes a tagged document supports appear in its detail.
What happens next
- Watch the case rows under How your evidence is being reviewed, and answer any request your expert raises against the document.
Related guidance
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.
European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices