Definition

Requirement that AI/ML tools used in PV have documented logic, inputs, outputs, and limitations so that decisions can be explained to regulators and inspectors.

Example

Documenting which features drive a signal score and how often the model is retrained.

Regulatory source

EMA reflection paper on AI in medicinal product lifecycle, FDA AI/ML guidance

Common mistakes

Using proprietary algorithms with no access to logic or validation report.

Inspector question

How do you ensure transparency of automated decision support in PV?

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