Lifecycle management
Time to Generate Is Not the ROI: Measure Time to Review
By Anant Agrawal, Head of AI, CIMCON Software. Based on my talk at ISPE on reviewing GenAI outputs The demo…
Lifecycle management
Why Pharma Needs Validated Software From Vendors, Not Internally Vibe-Coded Apps
A widely cited MIT study published in July 2025, “The GenAI Divide: State of AI in Business 2025,” analyzed 300…
Lifecycle management
Validation as a Service: IQ/OQ Protocols and Gap Assessments Without the Internal Build-Out
In February 2026, FDA finalized its Computer Software Assurance (CSA) guidance, reinforcing a risk-based, evidence-driven approach to computer system validation,…
Lifecycle management
AI Validation in Pharma: What FDA’s Final CSA Guidance Changes
In February 2026, FDA finalized its Computer Software Assurance (CSA) guidance, building on the 2022 draft version. For the first…