FDA QMM
FDA Quality Management Maturity,
operationalized.
Meet RegllerScore™ — your QMM number, computed daily from your own data. The same engine grades every internal assessment your organization runs.
From reactive compliance to quality as a number. FDA has been clear about what it wants. The companies that act early will shape what quality & compliance looks like for the next decade. Measure quality. Manage quality. Improve quality. Compliance follows.
Built on FDA QMM · 21 CFR · ICH Q10 · GAMP 5 · GxP · EU AI Act
What we measure
All five FDA QMM practice areas, scored daily.
A 1–5 verdict on each area. Rolled up to one RegllerScore.
Management Commitment to Quality
Leadership owns quality. Resourced like a strategic priority, not delegated downward. Executive-level decisions reflect quality maturity, not just compliance posture.
Business Continuity
Supply, capacity, and single-point-of-failure risks mapped, monitored, and rehearsed. Resilience built into the operating model, not added after a recall.
Advanced Pharmaceutical Quality System
Quality risk management is data-driven. The quality system detects drift early, not at the next audit. CAPA, change control, and complaint handling function as one closed loop.
Technical Excellence
Process and product knowledge governed and current. Data trustworthy and connected. Lab, manufacturing, and supply quality all speak the same language.
Employee Engagement
People closest to the work are recognized, trusted, and empowered to surface problems. The quality culture is visible in behavior, not just in posters.
What we believe
FDA QMM is the regulator’s structural response to a structural problem.
42% of U.S. drug shortages trace back to manufacturing quality. ~$500B in U.S. onshoring is creating dozens of new sites that cannot all be inspected the old way. FDA’s Quality Management Maturity program is the agency’s answer — and a clear signal to industry.
Manufacturers that engage with QMM early get inspection priority shifts, lighter review cycles, preferred-supplier standing with hospitals and payors, and cleaner M&A diligence.
Compliance gets you to 3 on the FDA five-point scale. The next two points — where the operational advantage and the business value live — are the work the regulator now actually wants you to do.
What’s at stake
What FDA wants. What industry gets.
Two sides of the same coin. Engage early — capture both.
Why FDA wants this
Patient access through reliable supply.
- 42% of U.S. drug shortages trace back to manufacturing quality.
- CGMP is the floor. QMM rewards operational resilience and predictive quality.
- ~$500B in U.S. onshoring creates dozens of new sites that can’t all be inspected the old way.
What industry gets in return
Regulatory and commercial advantage.
- Flexibility on post-approval changes and CMC submissions.
- Lighter inspection burden and faster review cycles.
- Preferred-supplier standing with hospitals, payors, GPOs — and cleaner M&A diligence.
- Established quality organization in the eyes of people & regulators.
Across FDA-regulated sectors
Industry maturity is not evenly distributed.
Cross-industry learning is an opportunity.
- • Even in pharma, most companies haven’t engaged with the QMM program yet. Opportunity to lead the change.
- • Biologics and medical devices sit close behind.
- • Animal health, food & beverage, and cosmetics can benefit even more from QMM.
- • Industries won’t have decades. Time to get involved is now — before FDA mandates QMM.
The Number
One RegllerScore. Drillable to the cell.
Your QMM number, refreshed daily from your own data.
- • Your RegllerScore (1–5) rolls up from site → function → asset → study. Click any cell to see the evidence.
- • Peer + industry benchmark. Quantified position vs. comparable companies. Strengths, gaps, where to invest first.
- • Improvement plan. Every gap ranked by score-impact-per-effort. Projected score uplift and COPQ savings before you commit a dollar.
Multi-site view
Multi-site maturity at a glance.
Every site, every function, scored and ranked.
From one site to the whole enterprise. See where you stand across every facility, every function, every asset — with the same score, refreshed daily. Drill any column to the batch record, the lab notebook, the deviation that contributed to the number. Quality leaders see signal, not noise. Site heads see what to fix this quarter. CEOs see whether the maturity number is moving — and where the next win comes from.
Beyond QMM
Every internal assessment, one engine.
The same engine that grades your FDA QMM number grades every other internal assessment your organization runs.
- FDA pre-audit and mock inspections.
- AI system audits — GAMP 5 Annex 22, EU AI Act.
- IT system assessments and infrastructure audits.
- SOX and financial controls.
- GxP — GMP, GLP, GCP — compliance.
- Vendor qualification and supplier audits.
- Internal audit programs across business units.
- One common report. Every audit. Every score.
Companies that adopt QMM-thinking across every internal assessment find the maturity number compounds — each score improvement helps every other score.
What you get
Quality as a number. Strategic. Operational.
The benefits land in the boardroom and on the shop floor.
Improve drug supply. Help patients in need.
- Reduce shortage risk by making quality predictive, not reactive.
- Win FDA regulatory advantage — and commercial preferred-supplier standing.
- Strengthen valuations and M&A positioning with a defensible quality story.
- Lead your sector before QMM shifts from voluntary to expected.
Faster audits. Fewer audits. Lower cost.
- FDA-aligned questions and data. No more subjective audit prep.
- Fewer audits needed. Continuous monitoring catches drift before it becomes a finding.
- Audit cost reduced up to 80%. AI extracts evidence, compares against 21 CFR, flags automatically.
- Inspection-ready as a state. Every signal, every site — always current.
How we start
Day 1. Day 30. Day 90. Then continuous.
Baseline in 30 days. A plan in 60. The score moving in 90.
Your QMM Score
A signal you can act on. Baseline 1–5 RegllerScore across all five FDA QMM practice areas.
Your Action Plan
Detailed assessment. A 90-day roadmap. Every gap ranked by score-impact-per-effort.
Your First Improvement
Proof your score moves. Quality, validation, audit-prep gains demonstrated.
Maturity Compounds
A score that keeps improving. Available as one-time, annual subscription, or managed program.
Who we serve
Every FDA-regulated industry. Every company size.
Startup through global enterprise — tailored to your size and current maturity.
Featured insights
Related reading.
What is FDA Quality Maturity Model (QMM)?
The framework FDA is using to push the industry past point-in-time compliance.
How quality maturity prevents drug short supply.
Quality maturity is the supply-chain resilience metric most CFOs aren’t looking at yet.
What FDA’s first QMM scorecard tells us.
FDA’s pilot cohort scored 2.40–4.62 on the five-point scale. The patterns inside the content.