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Let’s say the quiet part out loud. Most product problems don’t fail inspections because no one cared.They fail because everyone thought the problem was already handled. […]

CAPA Survival Playbooks — Kandih Bioscience FDA expects CAPA, design controls, and risk management to operate as one integrated risk-control system.If CAPA closes without updating design […]

CAPA Survival Playbooks — Kandih Bioscience A CAPA that does not result in a Design History File (DHF) update is not effective in FDA’s eyes.From an […]

CAPA Survival Playbooks — Kandih Bioscience From an inspection perspective, a CAPA that stops in QA without informing design inputs, risk management, or validation is incomplete. […]