EPISODE · Oct 16, 2025 · 16 MIN
From Paper Piles to Precision: Solving the CSV Puzzle
from Veeva Training Solutions Podcast
Join Nina Ricciardelli and expert John Cheshire as they debunk myths and explore the transformative power of risk-based digital validation. This episode uncovers how a smarter, more efficient approach to CSV can cut costs, accelerate system deployment, and better protect patient safety, all while meeting regulatory expectations. Learn practical steps to overcome cultural barriers, streamline your QMS, and drive real value in your validation journey, even without dedicated digital tools.Expert: John Cheshire, CSV Consultant, Headway Quality EvolutionExpert Links: Linkedin: https://www.linkedin.com/in/john-cheshireCompany Website: https://headwayqualityevolution.com/Validation Management Links:Join LinkedIn Community: https://www.linkedin.com/showcase/veeva-validation-management/?viewAsMember=true Book a Veeva Validation Management demo: https://calendly.com/veeva-val-management/30min LearnGxP Links:Join LinkedIn Community: https://www.linkedin.com/company/learngxp/Join Veeva Connect: https://veevaconnect.com/communities/ANhQ3gFSkAA/about?join=1 Book a Demo: https://learngxp.com/book-a-demo/
What this episode covers
Host Nina Ricciardelli and expert John Cheshire explore the shift from traditional, documentation-heavy CSV to a risk-based approach. This episode defines risk-based validation as an intelligent, targeted method focused on value, efficiency, and early identification of critical risks to enhance patient safety. They address common barriers like organizational culture and clarify that regulators emphasize validation goals over prescriptive documentation. The discussion also covers practical steps, like pilot schemes, for building confidence, necessary QMS adaptations, and the feasibility of risk-based validation even without dedicated digital tools. The core takeaway: begin by defining clear user requirements and intended system use.
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From Paper Piles to Precision: Solving the CSV Puzzle
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