Precision & Auditable Feature Suite
Enterprise modules engineered to eradicate human error and guarantee complete data integrity across validation lifecycles.
01. Protocol Data Entry & OOS
01. Protocol Data Entry & OOS
Cell-level data entry, real-time OOS (5.800 g) red border alerts, and automated RSD calculations.
02. AI Regulatory GAP Analysis
Scans protocols against EudraLex Vol 4 Chapter 4 and FDA Part 11 to output structured GAP analysis.
03. AI Document Q&A
Context-aware RAG assistant providing verified tolerance answers directly cited from your templates.
04. Template & Bulk Field Builder
Bulk table cell selector, lower/upper limits (5.3286 - 5.7159), and role authorization mapping.
05. Cryptographic Audit Trail
Immutable sequential audit log with user roles, LLM engine metadata, and raw JSON payload inspector.
1. Protocol Data Capture & OOS Boundary Alerts
Measurements violating cell-level tolerance boundaries (Min/Max) are instantaneously flagged with red borders. Mean, Min, Max, and RSD statistics calculate in real-time.
- Page View and Simplified Grid modes
- Real-time OOS boundary alert (e.g., 5.800 g & 5.306 g)
2. AI Regulatory GAP Analysis
Cross-examines validation documentation against EudraLex Vol 4 Chapter 4, EU GMP Annex 15, and FDA 21 CFR Part 11 standards to identify unassigned approvals and missing risk rationales.
- Automated GAP assessment report generation
- Article-level regulatory citations (§4.1 etc.)
3. Intelligent Document Q&A Assistant
Performs contextual semantic retrieval (RAG) across your validation templates, historical protocols, and FMEA sheets. Outputs verified citations with exact confidence scores (Score: 0.412).
- Verified excerpt citations & tolerance extraction
- Zero-hallucination, boundary-contained responses
4. Cryptographic Audit Trail
In compliance with FDA 21 CFR Part 11.10(e), all mutations are logged with UTC timestamps, user roles, IP origins, and SHA-256 digital signatures with inspectable raw JSON payloads.
- Tamper-evident immutable event ledger
- Model and statistics engine version tracking
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