Gesund Signal · Practical tool
The change receipt.
Keep the change, evidence, decision owner and follow-up in one conversation.
Use it before the next decision.
Start with the actual version or workflow change. Identify the evidence it affects, the questions still open and the person who owns the decision.
Use the receipt alongside your study protocol, change-control process and quality system. It is a discussion aid, not a certification or substitute for regulatory review.
Download the blank receipt ↓Ungated text template. Keep patient data and confidential details out of public copies.
Fictional worked example · No customer dataAn image-processing update
- Change
- Version 1.2 updates preprocessing for a new scanner configuration.
- Evidence question
- Does the performance evidence cover the affected acquisition conditions?
- Available evidence
- The original evaluation used the earlier scanner configuration.
- Open gap
- The new configuration has not yet been evaluated against the expert reference.
- Decision owner
- The product release owner, with clinical and RA/QA review.
- Next step
- Define the affected evaluation and acceptance criteria before deciding whether to release.
- Follow-up
- Record the result, decision rationale and any agreed monitoring response.
An evidence gap
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