VITAL: QA/QC
AUTOMATION
Validation & Intelligence for Total Assurance
The VITAL Advantage
PRECISION AT SCALE.
VITAL transforms labor-intensive, error-prone quality control into an efficient, automated, and auditable workflow, delivering measurable ROI across the drug development lifecycle.
Beyond process improvement, VITAL delivers a significant competitive advantage through precision at scale.
"Scale QC throughput without complexity
Faster quality checks & decision making
Lower operating expenses via automation
Complete audit trail for every action
Platform Demonstration
The VITAL Platform
VITAL is a source-connected QA/QC platform for traceable, study-aligned review across documents, sample logs, run packages, and reassay checks.
It provides unified access to LIMS, workbooks, binders, and instrument outputs, normalizing data for sample-level review and automated cross-source comparison without replacing existing operational systems.
Findings & Review
- • AI-Assisted QC Checklist Auto-Population
- • Source-Linked Findings for Human Confirmation
- • Rule-Based Flagging & Deviation Alerts
Sample Reconciliation
- • Cross-Source Join (LIMS, ELN, Quickbase)
- • Deterministic Mismatch Detection (Counts, Dates)
- • Automated Resolution of Formatting Differences
Analytical Run Review
- • Predose & Concentration Trend Analysis
- • Automated Acceptance Threshold Checks
- • Instrument vs. LIMS Cross-Check (Peak Area)
Reassay Verification
- • Reason for Reassay Validation (ELN & LIMS)
- • Eliminated/Unacceptable Result Cross-Check
- • Final Reported Concentration Traceability
Key Capabilities
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Source Connected
Unified access to LIMS, workbooks, binders, and instrument outputs for cross-source comparison.
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Dynamic Workflows
Phase-aligned QC from protocol understanding through sample validation, adaptable to any project.
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AI Assisted Rule Based Logic
Repeatable, auditable checks at the core of every comparison, ensuring deterministic accuracy.
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Targeted AI Assistance
AI supports extraction and interpretation of semi-structured documents while humans retain final authority.
Accelerated Development
Weeks 1-4: Phase 1
Data Connections & Core QC: Connect to LIMS, ELN; Sample Verification MVP.
Weeks 4-6: Phase 2
Study Design & Run Analysis: Protocol verification; Exception handling interface.
Weeks 6-8: Phase 3
QC Reporting & Reassay Analysis: Automated QC reporting; Full suite ready for production.
VITAL Across the Drug Development Lifecycle
Compliance & Data Sovereignty
GxP & 21 CFR Part 11
Built to support compliant electronic records, signatures, and rigorous audit trails for regulatory submission.
Local AI Inference
Models run locally on your private server—no external API calls, ensuring zero data leakage.
On-Premises Deployment
Fully contained within your infrastructure. VITAL delivers AI benefits without compromising sovereignty.
Human-Supervised AI
Every AI output is reviewed and signed off by a person before acceptance. AI does not make independent decisions.
SYSTEM INSIGHTS
Centralized Knowledge Base
Data Mapping & Ontology
Validation Checklist
Connected Data Sources
LIMS used for drug development study data; normalized for cross-source comparison.
No-code/low-code platform for tracking task workflows and sample-level review readiness.
ELN exports parsed into structured sample records; repositories provide study files and run packages.
Direct ingestion of instrument-generated PDFs and run package files for automated audit.