#Pharmaceutical Manufacturing
Browse all posts tagged with Pharmaceutical Manufacturing
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.
Exposing the Hidden Factory: How COPQ Reveals Capacity Constraints
March 18, 2026 • By Mike Barlow
The Hidden Factory represents unmeasured capacity consumed by internal failure activities such as deviation investigations, production rework, and documentation errors. While these activities are tracked operationally, their economic impact is rarely quantified. Applying the Cost of Quality framework translates this consumption into financial terms, providing a basis for capacity recovery and risk-informed prioritization aligned with ICH Q9 and Q10.
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.