Prevent Quality Failures Before They Happen
The Regller Quality Maturity Platform
AI-enabled quality monitoring and improvement platform for regulated life sciences and food organizations. Move from reactive compliance to predictive, risk-based quality improvement.
Our Mission
2 Billion
people worldwide lack regular access to essential medicines due to manufacturing quality issues.
Regller is driving the change!
Our mission is to make global healthcare and food systems safer by helping companies measure and improve quality maturity. We help your teams move from reactive firefighting to predictable, planned quality.
Regller is an AI-enabled quality maturity platform designed to help regulated life sciences and food organizations measure, manage, and improve quality maturity while reducing operational and regulatory risk. Built on FDA Quality Management Maturity (QMM) principles, Regller enables organizations to move from reactive compliance to predictive, risk-based quality improvement.
Platform Capabilities
The Regller platform is built using the full FDA Title 21 codes and aligns with FDA QMM principles to ensure quality is delivered Right The First Time.
QMM Assessment
Structured quality maturity assessments with QMM scoring, management review dashboards, and continuous improvement tracking aligned with FDA practice areas.
Validation Automation
Digitized computer system validation, CSA-based testing, and qualification workflows with audit-ready traceability and electronic approvals.
Site Qualification
Risk-based qualification of facilities, utilities, and equipment. Consistent GMP execution and inspection readiness across all manufacturing sites.
Quality Intelligence
Aggregates quality signals including deviations, CAPA, audits, and validation data to identify trends and emerging risks before they escalate.
Regulatory Templates
FDA Title 21-derived templates, audit questions, and validation structures. Standardized protocols and reporting across sites and functions.
Executive Dashboards
Color-coded quality maturity dashboards, risk heatmaps, trend analysis, and management review KPIs for enterprise-wide visibility.
Built for Regulated Environments
Regller is designed from the ground up for regulated industries:
- 21 CFR Part 11 — Electronic records and signatures compliance
- GAMP 5 — Risk-based approach to computer system validation
- ICH Q7 / Q10 — Pharmaceutical quality system alignment
- ALCOA+ Principles — Data integrity by design
- FDA QMM Program — Direct alignment with FDA quality maturity expectations
Expert Services
In addition to software, Regller provides expert services including platform implementation, computer system validation (CSV and CSA), GxP audits, inspection readiness, and design-thinking-based quality transformation. Together, Regller software and services help organizations strengthen quality culture, improve inspection outcomes, reduce the cost of quality, and build resilient, enterprise-wide quality systems aligned with global GxP expectations.
See the Platform in Action
Discover how Regller can help your organization achieve quality maturity.