#Computerized System Validation
Browse all posts tagged with Computerized System Validation
Artificial Intelligence in GxP Environments
April 6, 2026 • By Paul Van Buskirk
Artificial Intelligence (AI) in GxP environments is not a decision-making system—it is structured decision support aligned with GAMP 5. Most organizations get this wrong, positioning AI in ways that introduce unnecessary compliance risk. This whitepaper defines the correct framework—how to apply AI with discipline, maintain human ownership of decisions, and align with regulatory expectations without increasing validation burden.
BatchTrak™: Regulatory Alignment with ISPE and GAMP 5
March 16, 2026 • By Paul Van Buskirk, Mike Barlow
This whitepaper explains how the BatchTrak™ Manufacturing Operations Management platform aligns with ISPE Baseline Guide Volume 5 and GAMP 5 risk-based computerized system guidance for regulated pharmaceutical environments.