Audits
Intelligent audit management for pharmaceutical manufacturing. Every checklist AI-generated. Every risk scored. Every gap surfaced before the auditor arrives.
Schedule a demo
Audits
Intelligent audit management for pharmaceutical manufacturing. Every checklist AI-generated. Every risk scored. Every gap surfaced before the auditor arrives.
Schedule a demo
Built for Inspection Readiness
AI-generated audit checklists from regulatory guidelines. Predictive risk scoring to prioritise what matters. Real-time readiness dashboards that surface gaps before auditors do.
Leucine Audits transforms audit management from reactive firefighting into proactive readiness. AI generates checklists from FDA, EMA, and ICH guidelines. Risk scoring prioritises inspection areas based on quality signals across your operation. Evidence is collected automatically from connected quality systems. And readiness dashboards give you real-time visibility into compliance gaps, so you fix them before the auditor arrives.
AI-Generated Audit Checklists
AI generates comprehensive audit checklists from regulatory guidelines, historical findings, and risk assessments, ensuring no requirement is missed and every question is weighted by regulatory importance.
Regulatory Guideline Parsing.
AI reads FDA guidances, EMA guidelines, and ICH standards to generate checklists that cover every applicable requirement.
Historical Finding Integration.
Previous audit findings and 483 observations are factored into checklist generation, ensuring known weaknesses are re-examined.
Risk-Weighted Prioritisation.
Questions are ordered by regulatory risk, critical GMP requirements surface first, administrative items last.
Multi-Standard Coverage.
A single audit can map against FDA, EMA, MHRA, and ANVISA requirements simultaneously with gap analysis across jurisdictions.
Predictive Risk Scoring
AI aggregates quality signals from deviations, CAPAs, complaints, and environmental data to calculate real-time risk scores, telling you where to look before the auditor does.
Real-Time Risk Calculation.
Risk scores update continuously as new quality events occur, deviations, CAPAs, complaints, and environmental excursions all feed the model.
Area Risk Heat Maps.
Visual heat maps highlight high-risk areas, processes, and equipment, giving audit teams a clear picture of where to focus.
Inspection Priority Ranking.
AI ranks areas by audit priority based on risk score, time since last inspection, and regulatory history.
Trend-Based Prediction.
Historical patterns predict which areas are likely to fail inspection, weeks before the audit, not days.
Automated Evidence Collection
Evidence is gathered automatically from connected quality systems, batch records, deviation reports, training records, and environmental data, organised by audit requirement.
Cross-System Gathering.
Evidence is pulled automatically from Documents, Deviations, Learning, Environment, and MES, no manual searching or screenshot collecting.
Requirement-Based Organisation.
Collected evidence is mapped to specific audit requirements and checklist items, ready for auditor review.
Completeness Tracking.
Dashboards show which requirements have sufficient evidence and which have gaps, before the audit begins.
Photo & Video Capture.
Field evidence including photos, videos, and annotated observations is captured on mobile devices with GPS and timestamp metadata.
Real-Time Readiness Dashboards
Live dashboards surface compliance gaps, track remediation progress, and give management a clear view of inspection readiness, by department, site, and regulatory standard.
Gap Identification.
AI continuously compares your current compliance posture against audit requirements, flagging gaps as they emerge, not at audit time.
Remediation Tracking.
Every identified gap has an owner, a deadline, and a status, tracked from identification through resolution with full audit trail.
Department Scoring.
Each department receives a readiness score based on evidence completeness, open findings, and risk profile, enabling targeted preparation.
Executive Summaries.
One-page summaries for site leadership and quality heads showing overall readiness, top risks, and recommended actions.
Connected across the platform
See how Audits sends and receives signals across every LeucineOS app.
Audits
Signal cascade
Triggered by
CAPA effectiveness scheduled for audit
Supplier risk triggers audit schedule
Logbook entries auto-linked as audit evidence
FDA inspection notice triggers audit readiness
Triggers
Audit finding creates deviation
Audit observation triggers CAPA
Click again or press Esc to close
Audits
Signal cascade
Triggered by
CAPA effectiveness scheduled for audit
Supplier risk triggers audit schedule
Logbook entries auto-linked as audit evidence
FDA inspection notice triggers audit readiness
Triggers
Audit finding creates deviation
Audit observation triggers CAPA
Click again or press Esc to close
Want to see Audits run on your data?
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Running in production at 400+ GMP facilities
New Jersey, USA
Automated HBEL-based cleaning validation with risk-based protocol generation, ensuring continuous FDA and EMA compliance.
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See your site stay inspection ready.
AI-built audit checklists, risk-based scheduling, and automated evidence collection. Walk into every inspection with the gaps already closed.