#GAMP5
Browse all posts tagged with GAMP5
Human in the Loop Is Not Enough: Who Is Governing the Loop?
October 6, 2026 • By Paul Van Buskirk
Human-in-the-loop is necessary—but in GMP environments, it may not be enough. Effective AI governance also requires humans above the loop: defining the boundaries, knowledge, controls, and conditions under which AI is allowed to support the work.
You Ran the COPQ Calculator—Now Lead the Response.
May 6, 2026 • By Mike Barlow, Paul Van Buskirk
Visibility doesn’t fix execution. It exposes it. The COPQ calculator makes the cost visible—but visibility alone doesn’t change outcomes. Leadership action does. What comes next determines whether this remains a number—or becomes a turning point.
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.
GMPWit™ Whitepaper | Structured Productivity in GMP Environments
March 19, 2026 • By Paul Van Buskirk, Mike Barlow
GMPWit™ introduces structured productivity to GMP environments, improving how deviation investigations, CAPAs, and operational work are created—without impacting validated systems or regulatory compliance.
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.