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Software and digital systems used for case intake, processing, signal detection, or reporting; includes e-reporting, mobile apps, and cloud-based safety databases.
Electronic submission gateway for E2B(R3) to regulatory authorities.
GVP Module I, FDA 21 CFR Part 11, EU Annex 11
Deploying tools without CSV or documented URS/FS.
What validation documentation do you have for your PV IT systems?