Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Request an appointment now

The Experiment Worked: Why Scientific Rationale Disappears Before CMC

A July 29, 2026 Pharmaceutical Technology feature by Christian Olsen examines a recurring failure in biologics R&D: systems preserve experimental results while losing the reasoning behind them. As candidates move from discovery into lead optimization, CMC and scale-up, missing context
  • News
The Experiment Worked: Why Scientific Rationale Disappears Before CMC

FDA Expanded AI; Leadership Turnover Leaves Pharma With New AI Questions

The FDA has expanded artificial intelligence across regulatory reviews, inspections, and administrative work. However, the departure of former commissioner Dr. Marty Makary and other senior technology leaders has created uncertainty around the agency’s AI strategy. Although the FDA continues to
  • News
FDA Expanded AI; Leadership Turnover Leaves Pharma With New AI Questions

Hospital AI Warning; The Same Tools Could Threaten Pharma’s GxP Systems

Karen Habercoss, chief information security and privacy officer at the University of Chicago Medicine, warned that hackers and nation-states now use AI to automate and scale cyberattacks. Her warning extends beyond hospitals. In pharma operations, the same technology supporting QA
  • News
Hospital AI Warning; The Same Tools Could Threaten Pharma’s GxP Systems

Why Inspection Readiness Is Becoming Harder; Digital GMP Raises New Risks

In a recent interview with Christopher Cole of Pharmaceutical Technology, Henrik Johanning from Epista Life Science discussed how pharmaceutical manufacturing and regulatory systems in Europe are shifting from 2025 into 2026. He explained that quality risk management, digital GMP, and
  • News
Why Inspection Readiness Is Becoming Harder; Digital GMP Raises New Risks

computer system validation in pharma in 2026: compliance and inspection expectations

Computerized systems now sit at the center of regulatory expectations in pharma operations. This article explores how validation practices, audit trail control, and structured documentation support inspection readiness while aligning with evolving pharma CSV requirements and compliance standards.
  • Blog, Computerized System Validation
Laboratory environment showing pharmaceutical data integrity systems with audit trail monitoring and validation checklist aligned with GAMP 5 validation lifecycle