Definition

Software and digital systems used for case intake, processing, signal detection, or reporting; includes e-reporting, mobile apps, and cloud-based safety databases.

Example

Electronic submission gateway for E2B(R3) to regulatory authorities.

Regulatory source

GVP Module I, FDA 21 CFR Part 11, EU Annex 11

Common mistakes

Deploying tools without CSV or documented URS/FS.

Inspector question

What validation documentation do you have for your PV IT systems?

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