Welcome to CSV Cafe.

Where compliance meets conversation.

Hosted by JJ Espinosa, Partner at GxP-CC, together with AI co-host Linda, this channel explores the real-world side of Computer System Validation (CSV), Computer Software Assurance (CSA), and digital governance in regulated GxP environments.

From inspection readiness and risk-based validation to SaaS implementations and cross-functional alignment, we break down complex regulatory expectations — including guidance from the U.S. Food and Drug Administration, 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 — into practical leadership conversations.

No panic.
No last-minute scrambling.
No compliance theater.

Just structured thinking, operational discipline, and a culture of readiness.

Grab a coffee — or any beverage of your choice.
In this Cafe, all time zones apply.

Join the discussion.
Build validation maturity the right way.

Learn more at: www.gxp-cc.com