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Quality Intelligence That Predicts Risk—Before Others Do
Regller Quality Intelligence
Transform regulatory data, quality signals, and operational evidence into actionable risk insight.
Quality risk is no longer driven by isolated deviations or individual audit findings. Regulators increasingly evaluate organizations based on patterns—repeat issues, weak controls, inconsistent execution, and lack of management oversight. Yet most companies still manage quality risk reactively, relying on manual reviews, lagging indicators, and fragmented data sources.
Regller Quality Intelligence brings together regulatory knowledge, structured assessments, operational data, and AI-enabled analytics to predict, prioritize, and prevent quality risk—before it escalates into FDA observations, warning letters, recalls, or supply disruptions.
Industry Challenges
Most organizations struggle with:
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Quality data scattered across audits, deviations, CAPA, validation, and documents
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No consistent baseline to measure compliance or maturity
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Overreliance on periodic audits and subjective judgment
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Limited ability to identify systemic or repeat issues
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Inability to anticipate inspection outcomes
Built on Regulatory Truth, Not Guesswork
Regller Quality Intelligence is grounded in regulatory source data, not generic risk models.
From these sources, Regller has built thousands of structured, traceable assessment questions, controls, and evidence expectations that define what “good” looks like from a regulatory perspective.
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FDA Title 21 CFR (decoded and structured)
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FDA Quality Management Maturity (QMM) framework
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ICH guidelines (Q8–Q12)
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GAMP 5 and CSA principles
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Global GMP and inspection practices
Quality intelligence and Inspection insights
Learning from FDA and Global Inspections
Regller maps internal quality data to external regulatory signals, including:
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FDA inspection trends
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Publicly available FDA 483s and warning letter themes
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Repeat and systemic issue patterns
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Industry-wide enforcement focus areas
By correlating internal weaknesses with known inspection outcomes, Regller helps organizations understand:
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Where regulators are likely to focus
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Which gaps are most likely to escalate
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How internal quality signals translate into regulatory risk