Definition

Documented evidence that computerized PV systems consistently perform as intended and meet GxP requirements (GVP Module I, Annex 11).

Example

IQ/OQ/PQ for safety database, e-reporting gateway, and signal detection tools.

Regulatory source

GVP Module I Rev 4, EU Annex 11, FDA 21 CFR 11

Common mistakes

Treating vendor validation as sufficient without site-specific URS and testing.

Inspector question

Show me the validation summary for your safety database.

Related terms