Audit-Proof Automation: Releasing AI Features in a Validated State
Gillian Gittens and Jay Smith address the critical requirements for releasing AI features in a validated state that meets regulatory scrutiny.
WATCH THE FREE WEBINAR: Risk-Based CAPA Under ICH E6(R3)
Create, review, and archive clinical content. Launch compliance focused training. Index all required records in the eTMF
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Make it easy to show the story of your study to regulatory agencies.
Audit-Proof Automation: Releasing AI Features in a Validated State
Gillian Gittens and Jay Smith address the critical requirements for releasing AI features in a validated state that meets regulatory scrutiny.
Beyond Surface-Level: AI Deep Inspection of eTMF Records for Quality & Compliance
Jay Smith and Katherine Cianciarelli explore advanced AI applications for comprehensive eTMF document inspection that goes beyond basic compliance checks.
MHRA Inspection Insights Part 2: The Metrics That Matter
As regulators adopt the principles of ICH E6(R3), the MHRA is taking a closer look at how organizations apply risk proportionate oversight, quality by design, and documentation that proves control.