AI-Enabled FDA Quality Maturity Software
Built on FDA Quality Maturity Model (QMM) and CFR Title 21 to move from reactive compliance to quality maturity score for excellence.
Regller helps life sciences and food organizations measure, benchmark, and improve quality maturity score using FDA-aligned frameworks, automation, and AI-driven risk intelligence.
The quality gap is costing billions — and milions of lives.
Despite decades of regulation, quality failures still cause drug shortages, recalls, and wasted investments. Each year, life-sciences companies spend over $200B fixing preventable issues.
“When quality fails, patients lose access to medicine.”
2 Billion
People worldwide lack regular access to essential medicines
60%+
Drug shortages are caused by manufacturing and product quality problems
85%+
Recalls are triggered by quality failures at the manufacturer level
225 Billion
Cost of quality in the life sciences segment. Food segments adds far more
Regller is Raising Global Quality Standards
Add Regller is helping raise the quality bar for safe medicine. Regller™ is a next-generation AI-driven SaaS platform transforming how life sciences and food industries measure, automate, and elevate quality. It bridges the gap between point-in-time compliance and continuous quality improvement — helping global manufacturers achieve higher Quality Maturity Levels (QML) and sustained operational excellence.
From Quality Data to Predictive Quality Intelligence
Regller transforms thousands of regulatory questions, FDA inspection trends, and operational quality signals into:
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Quality maturity scores
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Risk heatmaps and roadmap to improve quality maturity score
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Continous monitoring, AI driven audits for inspection risk indicators
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Early warning signals for supply disruption
By analyzing documents, systems, and quality data together, Regller enables organizations to prevent quality failures instead of reacting to them.
Regller Quality Risk to Remedy Solution!
The Industry Shift
A smarter way to build quality — FDA’s QMM Framework.
The FDA’s Quality Management Maturity (QMM) initiative encourages continuous quality excellence — not just compliance.
The Regller Solution
Regller Software Platform brings the QMM vision to life through software that measures, automates, and improves quality maturity — globally. Regller makes QMM practical and measurable.
How Regller Platform Does It?
Built on FDA Title 21. Operationalized through FDA QMM. Regller embeds regulatory compliance and quality maturity into a single quality operating system.
Benchmark
Measure your quality maturity with the Regller QMM™ Score — transparent, comparable, and actionable.
Quality Improvement Plan
Standardization & Automation
Use built-in templates and workflows to standardize, reduce manual effort and consistent quality.
AI enabled standardization & Automation
Risk Prediction & Prevention
AI identifies risks before failures — helping you deliver quality products every time risk free.
Quality is a continuous journey. Monitor it
Peopleplace
A global network where quality experts share templates, insights, and earn from their expertise.
Quality & Compliance Network for faster & better results
How Regller Helps Businesses
01- Know Your Quality
A global life sciences organization operates multiple manufacturing sites with varying quality practices. Leadership lacks a consistent, objective way to understand quality maturity across sites or to prioritize improvement investments aligned with Quality goals. However, inconsistent work products, subjective assessments, reactive and fragmented monitoring can lean into inconsitent quality product.
In addition, despite huge investment in quality, most companites or site or functions do not have the vsibility of the current quality status. They are highly dependent on the subjectivity and sporadic quality aiduts.
Regller Solution
Regller gives a quality scanner that can exactly tell the current quality status. A dashboard color helps identify the critical deficiencies for quick remediation.
Explore Regller QMM Benchmarking Solution.
02- Qualify Site with AI Templates
A company is bringing a new manufacturing site online for production or modifying the current site that must ensure GMP readiness while qualifying facilities, utilities, and equipment. Multiple teams and vendors are involved, creating inconsistencies, documentation gaps, and limited visibility into readiness status.
Regller Solution
Regller Site Qualification standardizes and digitizes qualification activities using a risk-based approach derived from regulatory expectations. A standard template based approach that is fully aligned with FDA Title 21 requirements (GxP) that is executed by advanced AI technologies to ensure site qualification is achieved Right The First Time. Real-time visibility into qualification progress and gaps helps teams accelerate readiness and reduce inspection risk.
See Regller Site Qualification in Action.
03- Validation Automation
An organization is implementing new systems but lacks sufficient validation bandwidth. Manual CSV processes slow deployment, increase documentation burden, and create inconsistency across systems and projects.
Regller Solution
Regller Validation Automation digitizes validation planning, execution, traceability, and approvals using a CSA-aligned, risk-based approach. Teams reduce manual effort while maintaining audit-ready validation and faster system deployment.
Learn About Regller Validation Automation.
04- Risk Prediction and Prevention
An organization continues to experience repeat deviations even after serious investment in right systems and repeated audits but lacks early warning signals to prevent issues before they impact compliance or supply continuity. Quality data is siloed and reviewed reactively. The issues were due to lack of mapping their existing processes with the GxP expectations.
Regller Solution
Regller aggregates quality signals across systems and applies AI-enabled monitoring to identify trends, repeat issues, and emerging risks early—supporting proactive intervention and sustained quality control. This is done using the Title 21 decoding and creating document templates, checklists and audit questionnaires that ensure the compliance. However, the bigger benefit of using standard processes and templates are to ensure the right quality output everytime without fail.
Discover Regller Risk Prediction & Prevention.
Regller is grounded in two regulatory foundations
THE FOUNDATION: FDA QMM and CFR TITLE 21
FDA Quality Management Maturity (QMM)
A forward-looking framework that evaluates management oversight, process performance, and continuous improvement beyond traditional GMP inspections.
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FDA CFR Title 21 (GxP Foundation)
The regulatory backbone of pharmaceutical, biotech, medical device, and food compliance. Regller has decoded Title 21 into structured assessments, audit questions, templates, and validation workflows.
Why Regller?
QMM Made Practical. Maturity Made Measurable.
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Built natively on FDA QMM and Title 21. The platform ensures adherence to GxP and QMM guidelines.
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Works with the principle of knowing where you stand (assessment), where you want to reach (QMM Score) and what exact actions you need to take
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Designed for predictive, risk-based quality improvement
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Combines assessment, automation, and intelligence
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Scales across sites, functions, and products
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Supports regulators, manufacturers, and consultants
Start Measuring Quality Maturity
We want to help improve quality of medicine and food. To improve quality, we need to focus on quality. Historically, companies left quality in the hands of compliance. We are here to make that change-- improve quality...you will be compliant automatically.
We are addressing many challenges:
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Quality maturity is unclear
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Validation takes too long
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Site qualification is manual
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Audits are stressful
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Data sits in many systems
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Risks hide until it’s too late
Regler brings everything into one clean workflow — assessment, automation, and action.