Signal detection: person or process?

GVP Module IX requires a systematic, traceable signal detection process: continuous, documented and reproducible. Not a good analysis, but one that can be repeated and justified.

In practice, precisely this often depends on a single experienced person. They know the portfolio, they spot anomalies, they know from experience which trend deserves attention. As long as they are there, this works well.

The problem is not their work. The problem is that this work is not written down anywhere.

Would your process pass the inspection if this person were unavailable tomorrow?

The answer to this is not a staffing question. It is the standard an inspection applies in any case: a system that only works through personal knowledge is not a documented system.

Three elements make the difference between signal management you can present and one that merely runs:

• Documented methodology — data sources, frequency, thresholds and assessment logic are laid down in writing.
• Traceable decisions — every signal assessment is available with its rationale and audit trail, including those that did not lead to any further step.
• Roles and deputies — responsibility is tied to functions, not to individual names.

If you cannot answer these three points for your own system in a few sentences, it is worth taking a look before an inspection is announced. We would be happy to review this with you.