Are pharma companies ready for FDA audits of eLogs and digital batch records?
Can LLM-based quality systems pass an FDA Part 11 audit?
Can AI-generated procedures or RCA reports be considered FDA-compliant?
How will AI-driven inspection models change FDA audits in the next 5 years?
Top Repeat FDA Violations: What Keeps Getting Companies in Trouble?
What is the FDA’s new AI tool “Elsa” and how does it impact inspections?
Are pharma companies ready for FDA audits of eLogs and digital batch records?
The shift from paper to electronic logs (eLogs) and electronic batch records (eBMRs) is accelerating…
Can LLM-based quality systems pass an FDA Part 11 audit?
Yes, but only with work, evidence, and a strong control framework. Large language model (LLM)-based…
Can AI-generated procedures or RCA reports be considered FDA-compliant?
AI can help generate procedures and Root Cause Analysis (RCA) reports, but AI-generated documents are…
How will AI-driven inspection models change FDA audits in the next 5 years?
AI-driven inspection models will enable FDA audits to be faster, more data-driven, and more focused…
Top Repeat FDA Violations: What Keeps Getting Companies in Trouble?
Repeat FDA violations keep showing up across drug, biologic, and device manufacturers because problems are…
What is the FDA’s new AI tool “Elsa” and how does it impact inspections?
The FDA’s new internal generative-AI assistant ELSA (Enterprise Language Support Assistant) is an agency-wide tool…