Quality decisions, powered by AI
From deviation to CAPA to batch release - QualityAI automates regulatory compliance, surfaces FDA precedents, and predicts risk before it impacts your product.
21 CFR 11
Part 11 Compliant
<30s
AI Analysis Time
100%
Audit Trail Coverage
50+
FDA 483 Categories
Open Deviations
12
Overdue CAPAs
3
Batches in Review
8
Compliance Score
94%
Recent Deviations
View All →Compliance Scores
Change Control score dropped 12% this month. 3 overdue reviews detected - recommend immediate escalation.
Capabilities
Everything pharma QA needs. Nothing it doesn't.
Six integrated modules that replace spreadsheets, manual reviews, and compliance guesswork with AI-driven precision.
AI-Powered Deviation Analysis
Claude AI writes deviation reports, identifies root causes with 5-Why and Ishikawa analysis, and recommends CAPAs - all within seconds, not days.
FDA 483 Precedent Matching
Automatically cross-reference deviations against 50+ FDA 483 observation categories. Get tailored mitigations with exact CFR citations before the auditor does.
Predictive Batch Risk Scoring
AI analyzes historical deviation patterns, severity trends, and open CAPAs to predict batch risk at upload - flagging high-risk batches before they reach QA review.
21 CFR Part 11 Compliant
Electronic signatures with SHA-256 hashing, re-authentication enforcement, complete audit trail with 31 triggers, and role-based access across 7 configurable roles.
Live Compliance Dashboards
Real-time KPI tracking with 30-second polling. Compliance scores by audit area, overdue CAPAs, batch review times, and risk distribution - all auto-refreshing.
End-to-End Batch Lifecycle
PDF upload → AI parsing → field extraction → automated review → QA approval → electronic release. The entire batch record workflow, digitized and intelligent.
Product
See the intelligence in action.
Every deviation gets a full AI workup - root cause, 5-Why analysis, FDA precedent matching, and CAPA recommendations - in under 30 seconds.
From deviation to CAPA
in 30 seconds.
Upload or log a deviation and watch Claude AI dissect it - root cause identification, Ishikawa diagram, 5-Why drill-down, and three actionable CAPA recommendations. Each analysis cross-references your historical deviations and FDA 483 observation database.
Root Cause (AI)
HVAC compressor failure in Cold Storage Unit B led to 4.2°C excursion over 6 hours
5-Why Analysis
BATCH-2024-0891
Metformin 500mg
Risk
23
BATCH-2024-0892
Omeprazole 20mg
Risk
78
BATCH-2024-0893
Amoxicillin 250mg
Risk
45
BATCH-2024-0894
Lisinopril 10mg
Risk
12
BATCH-2024-0892 flagged: 3 related deviations in past 30 days, 2 open CAPAs on same product line. Recommend escalation before release.
Know the risk
before the auditor does.
Every batch gets an AI-computed risk score at upload. The model analyzes historical deviation patterns, open CAPAs, product line trends, and severity distributions to flag high-risk batches before they reach QA review.
Compliance
Built for regulated environments.
Every feature designed with GxP compliance in mind - from electronic signatures to complete audit trail coverage.
21 CFR Part 11
FDA Electronic Records
EU GMP Annex 11
Computerised Systems
ICH Q10
Pharmaceutical Quality System
ISO 13485
Medical Device QMS
SOC 2 Type II
Security & Availability
GAMP 5
Computer Validation
SHA-256
Signature Hashing
31
Audit Trail Triggers
7
Configurable Roles
100%
Re-auth Enforcement
How It Works
Four steps to audit-ready.
From raw data to regulatory compliance - fully automated, fully traceable, fully compliant.
Upload & Capture
Upload batch record PDFs or log deviations through structured forms. AI extracts fields, identifies document types, and creates structured records - no manual data entry.
AI Analysis
Claude AI performs root cause analysis, generates 5-Why drill-downs, creates Ishikawa diagrams, and computes risk scores - transforming raw data into actionable intelligence.
Regulatory Cross-Reference
Every deviation is matched against FDA 483 observation categories with CFR citations. Get audit-ready mitigations and compliance gap analysis before the inspector arrives.
Review & Release
QA reviews AI recommendations, applies electronic signatures with SHA-256 hashing, and releases batches - all within a 21 CFR Part 11 compliant workflow with complete audit trail.
Stop reacting.
Start predicting.
Join forward-thinking pharma companies using AI to cut deviation investigation time by 90%, predict batch risk before release, and stay ahead of FDA expectations.