What is FDA Quality Maturity Model (QMM)?

By Regller Team | March 2026 | 3 min read

The FDA Quality Maturity Model (QMM) is a framework developed by the U.S. Food and Drug Administration to evaluate how effectively pharmaceutical manufacturers manage quality. FDA’s Center for Drug Evaluation and Research (CDER) established the QMM program to encourage quality management practices that go beyond current good manufacturing practice (CGMP) requirements.

Why QMM Matters

QMM shifts the conversation from “Are we compliant?” to: Are we consistently capable? Are we resilient under stress? Do we detect and prevent issues early? The goal is improving reliability and reducing quality-related disruptions.

How Regller Helps

Regller transforms QMM into a scalable, digital, and objective maturity standard. We help teams move from reactive firefighting to predictable, planned quality. Get your assessment done using Regller QMM software to know your quality maturity level.