A complaint legally requires CAPA when it signals loss of control in the quality system—not when it hits a numeric or procedural threshold.From an FDA enforcement […]
CAPA Survival Playbooks — Kandih Bioscience If your CAPA depends on complaints—but your complaint handling system is weak—your CAPA is already dead.From an FDA inspection perspective, […]
CAPA Survival Playbooks — Kandih Bioscience CAPA does not sit in QA.From an FDA inspection perspective, CAPA sits at the intersection of complaints, design controls, supplier/CMO […]
CAPA Survival Playbooks — Kandih Bioscience CAPAs Don’t Fail at Closure—They Fail at the Source Most CAPA programs don’t fail because teams can’t write corrective actions.They […]