Operationalizing FDA’s QMM Vision for All Industries—at scale
Regller™ helps manufacturers measure, improve, and sustain Quality Management Maturity (QMM) using FDA-aligned practice areas, auditable evidence, and executive dashboards—so quality becomes predictable, not reactive.
Regller™ transforms the QMM framework into a scalable, digital, and objective maturity standard. We help your teams move from reactive firefighting to predictable, planned quality. Get your assessment done using Regller QMM software to know your quality maturity.
QMM is not an inspection—and not a one-time project.
FDA and industry discussions emphasize that Quality Maturity Model (QMM) is intended to evaluate the maturity of quality management practices at a site—distinct from a typical CGMP inspection—and is centered on how quality systems are designed, led, measured, and improved over time.
Regler view
Treat QMM as a continuous initiative. Standardization, Automation, Monitoring & Prediction of Risks can drive quality improvement. Regller Platform is designed to achieve this.
Regller™ QMM Software
Regller follows a structured, repeatable assessment process to establish quality maturity baselines and enable continuous improvement aligned with FDA QMM principles.
Each assessment is aligned with FDA Title 21 codes to ensure compliance requirements. QMM Scores are defined as QML- quality maturity level. QMM scoring is mapped to Title 21 expectations.
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QMM assessment score for each assessment
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Track assessment score improvements
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Every assessment creates two results-- manual score and automated AI score
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Setup automated assessment to run at pre-defined schedule savings people audit time
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Maturity reflects capability to comply, not just outcomes
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Management review aligns with regulatory intent
Scope is aligned with your operations
Define assessment scope across sites, functions, and processes. Align assessment criteria to FDA QMM practice areas and Title 21 requirements.
Why Regller QMM
QMM Made Practical. Maturity Made Measurable.
Meet FDA Title 21 Requirements.
Title 21 Alignment
Documents, templates, and audit questions derived directly from FDA Title 21 requirements.
Clear linkage between regulatory expectations, evidence, actions, and outcomes.
Risk Based Prioritization
Automated identification of high-impact risks using leading indicators and trend analysis.
FDA QMM Aligned
Structured assessment model aligned with publicly described FDA QMM practice areas.
Management Aligned
Full alignment with company's management commitment. Executive dashboards and governance workflows supporting effective leadership oversight.
Part11 compliant solution.
Enterprise Visibility
Cross-site, cross-function visibility into quality status, trends, and maturity. Visibility amongst peer group for quality differentiation.
Color Coded Dashboards
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Quality Maturity Overview – Enterprise and site-level maturity scoring by QMM category
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Quality Maturity Overview – Enterprise and site-level maturity scoring by QMM category
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Risk Heatmaps – Early warning signals highlighting emerging quality risks
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Trend Analysis – Maturity progression and repeat issue tracking over time
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Management Review Dashboards – KPIs aligned to governance and decision-making
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Improvement Tracking – Action status and effectiveness monitoring
FDA QMM
FDA’s Center for Drug Evaluation and Research (CDER) is establishing a Quality Management Maturity (QMM) program to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements. U.S. Food and Drug Administration
The QMM effort is designed to promote stronger quality management and a stronger quality culture, with the broader goal of improving reliability and reducing quality-related disruptions.
QMM shifts the conversation from “Are we compliant?” to:
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Are we consistently capable?
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Are we resilient under stress?
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Do we detect and prevent issues early?
FDA has described how QMM ratings could help stakeholders better understand site quality management practices and potentially inform decisions that impact supply reliability and oversight planning.
Supporting FDA’s Vision for Quality Maturity
FDA defines the vision for quality maturity. Regller provides the digital foundation to make that vision measurable, scalable, and actionable across the industry.
FDA Vision
Regller Solution
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Strengthen manufacturing reliability to prevent drug shortages and protect patients.
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Regller enables early identification of quality and maturity risks that historically lead to supply disruptions. By correlating quality maturity indicators with operational and inspection data.
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Shift from reactive oversight to predictable, performance-based quality outcomes.
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Regller transforms quality from a subjective assessment into a measurable, repeatable maturity signal. Standardized questions, objective scoring, and consistent benchmarking allow manufacturing quality to be evaluated predictably across sites, products, and organizations, reducing variability driven by interpretation or assessor differences.
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Encourage sustained quality behaviors beyond point-in-time regulatory compliance.
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Regller operationalizes continuous improvement by embedding QMM assessments into an ongoing digital lifecycle — assess, benchmark, improve, monitor. Compliance becomes an input, not the endpoint. This supports FDA’s intent to promote ongoing maturity advancement rather than episodic inspection readiness.
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Enable broad, consistent adoption of quality maturity principles across the industry.
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Regller operationalizes continuous improvement by embedding QMM assessments into an ongoing digital lifecycle — assess, benchmark, improve, monitor. Compliance becomes an input, not the endpoint. This supports FDA’s intent to promote ongoing maturity advancement rather than episodic inspection readiness.
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Encourage quality as a strategic capability, not just a regulatory obligation.
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Regller reframes quality as a strategic, data-driven capability by linking maturity scores to operational outcomes, risk signals, and improvement opportunities. This reinforces FDA’s message that strong quality systems reduce regulatory burden, improve reliability, and ultimately protect public health.
Be the change
Is QMM mandatory?
FDA has described QMM as a program and has operated voluntary prototype assessment protocol evaluation efforts.
Is QMM the same as a CGMP inspection?
Public discussions distinguish QMM assessments from typical inspections by focusing on maturity of quality management practices.
Does Regler provide an FDA rating?
No. Regler provides internal readiness scoring aligned to publicly described QMM practice areas to help you prepare and improve.
What sites should start first?
Start where the impact is highest: constrained products, high-volume sites, complex supply chains, or sites with recurring quality signals.