Find here all our blog posts tagged with: GxP.

Abstract image of glowing molecular data threads converging into an automated laboratory arm.

The Traceability Debt Building Inside AI-Native Drug Discovery

Closed-loop AI discovery platforms are compressing timelines faster than biopharma governance functions can build the audit trail regulators will eventually demand.

Abstract image of a molecular structure connected by glowing data pathways to laboratory equipment, symbolizing AI-driven drug discovery and data provenance.

AI-Native Drug Discovery Needs Provenance Records, Not Just Speed

As generative AI moves into candidate generation and synthesis, sponsors must build data lineage and model audit trails before IND filing, not after.

Rows of archived clinical trial samples in cold storage, with one vial illuminated as if being re-examined by new analysis.

The Next Regulatory Question Isn't the Model. It's the Data It Rescued.

AI-driven reanalysis of failed clinical trials is producing new evidence outside the systems built to validate it, and GxP quality frameworks have not caught up.

A glowing network of light connects a laboratory vial to abstract molecular structures, symbolizing AI woven into drug discovery.

Clinical AI's Financial Case Is Made. Its Audit Trail Isn't.

Drug discovery and trial AI are proving their financial return faster than sponsors are building the validation records to defend that work at inspection.

Two blank-faced clocks set at different times facing each other in a sterile laboratory corridor, symbolizing divergent regulatory timelines.

EMA Moved First on AI. FDA Is Still Deciding How.

EMA's lifecycle-wide AI reflection paper and FDA's still-open genAI device rulemaking are running on different clocks, and neither is finished business for regulated buyers.

A clock partially submerged in water with its gears exposed, symbolizing a regulatory deadline that has moved but not disappeared.

The EU AI Act Extension Is a Delay, Not a Reprieve

The Digital Omnibus pushes the EU AI Act high-risk deadline for medical devices to August 2027, but MDR/IVDR and EMA already require the same work now.