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Tag: GxP compliance

GxPVigilance

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Clinical operations professional reviewing regulatory documentation while analysing validation and performance data on a laptop dashboard

AI Hub, GxP Auditing12 hours ago

Computer System Validation in Clinical Trials

Professionals reviewing inspection readiness and Part 11 documentation alongside a validated digital system in a regulated environment

GxP Auditing2 days ago

Understanding 21 CFR Part 11 Requirements

A team of pharmaceutical quality and compliance professionals reviewing data integrity reports and audit documents during a meeting.

Development, GxP Auditing, PharmacovigilanceNovember 12, 2025

Quality and ALCOA+ Principles: Building Data Integrity You Can Defend Under Inspection