We write about audits, QMS, and regulatory change: field notes from building and running document audits.
QA teams are quietly using ChatGPT to draft SOPs, and inspectors are noticing. This piece covers the 4 compliance problems and a defensible framework for AI-assisted document development.
Read →QMSR killed the audit-records exemption. FDA can now inspect your internal audit reports, management review minutes, and supplier audit records. This is what it means for your next inspection.
Read →The February 2, 2026 QMSR deadline has passed. This covers what FDA inspectors are looking for, and how to verify your transition is complete.
Read →CAPA topped FDA warning-letter violations in FY2025. This piece names the 3 red flags of ineffective CAPA, and a root-cause framework that actually prevents recurrence.
Read →CDER warning letters surged 50% in FY2025. This piece names the supplier compliance findings that keep appearing in 483s, and what you can actually do about them.
Read →Document-control violations account for 60%+ of FDA 483s. This piece covers the 5 critical mistakes that fail audits, and how to fix them before your next inspection.
Read →AI can accelerate gap assessments, but generic tools introduce hallucination and audit-trail risks. This piece lays out a 5-point framework for using AI responsibly in compliance work.
Read →FDA warning letters for supplier-control failures cost $2.3M on average to fix. Check whether your quality agreements meet 21 CFR 820.50 and ISO 13485.
Read →Regulatory changes, and what they mean when an auditor is in the room. Unsubscribe in one click.
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