Reading time: 14 minutes | Last updated: December 2024 A gap analysis is the first real step in QMSR transition—and possibly the most important. Without understanding exactly where your current QMS falls short of QMSR requirements, you're guessing at priorities, likely wasting effort on low-impact changes, and potentially

The QMSR deadline is not a suggestion. February 2, 2026 is when FDA expects compliance. Not "making progress." Not "mostly there." Compliance. What Non-Compliance Looks Like If FDA shows up and your QMS doesn't meet QMSR requirements: 483 Observations.y.

Your Free Resources → QMSR vs 820 Cheatsheet — Side-by-side comparison of what actually changed → Top 10 QMSR Gaps Checklist — Priority-ranked gaps with fix recommendations → FDA Audit Day Guide — What to do before, during, and after an inspection