AI-Powered Review
AI validates every parameter and document so your team can focus on what needs attention.
Reduce Batch Review Time up to 70%
Mareana's Batch Review Copilot replaces manual QA bottlenecks with AI-driven, Review by Exception, so your team focuses on what matters.
Trusted by global
pharma teams
pharma teams
From Manual "Review Fatigue" to Strategic Quality Oversight
Pharmaceutical QA teams spend 60–70% of their review cycle on manual validation, cross checking ranges and hunting through siloed data.
AI processes 100% of batch data automatically
Only critical exceptions are surfaced
Faster, audit-ready review decisions with confidence
Traditional Manual Review
100%
Data Manually Reviewed
Mareana Review-By-Exception
~10%
Exception Reviewed By You
How the AI Rule Engine Verifies BatchRecords in Seconds
An AI rule engine ingests data from LIMS, ERP, and batch records, validates hundreds of parameters against specifications and historical trends, then surfaces only critical exceptions in a color-coded dashboard for human decision.
Data ingestion
Connectors pull parameter values from LIMS, ERP, and scanned documents via AI-OCR, ensuring all batch data is captured automatically without manual effort.
Data structuring
Ingested data is standardized and mapped into structured formats, making it ready for consistent validation across systems and workflows.
Rule Engine Validation
Validation library checks ranges, signatures, and calculations in parallel, ensuring every parameter meets predefined pharma-specific rules and standards.
Anomaly detection
Proprietary algorithms compare current values against historical distributions, identifying deviations and surfacing only meaningful out-of-trend conditions.
Immutable audit trail
Decision and revisions persist as immutable records for a permanent 21 CFR Part 11 trail, ensuring full traceability of every validation decision and action taken.
Review By Exception
Reviewers see parameter cards with source snippets and one-click controls, enabling faster decision-making by focusing only on flagged exceptions.
Everything You Need for Faster, Audit-Ready Batch Review
From data ingestion to exception-based review, Mareana automates review, surfaces critical issues, and ensures full traceability, so your team can review faster with confidence.
Intelligent Exception Management
Only critical issues are surfaced, prioritized, and explained with AI-driven insights.
Complete Batch Context
All critical information in one place for faster understanding and confident decisions.
Audit & Compliance
Every action is logged. Every decision is traceable.
Review with Confidence
Make faster, audit-ready decisions with full transparency.
Pharma-Specific AI Validation: From Batch-Specific Calculations to Signature Verification
Batch Review Copilot provides a configurable rule library with Python hooks for molecule-specific calculations, automated signature verification, range checks, and CAPA status validation, all designed for GxP environments.
Intelligent Rule Engine
Executes range checks, signature completeness, and Potency/Yield math via Python hooks in parallel.
AI-Powered Anomaly Detection
Identifies process drift by comparing current batch values against historical distributions.
Continuous Learning Control
Model retrains on reviewer decisions under strict validation logging protocols.
Why Teams Move Beyond Generic OCR & RPA
Generic tools weren’t built for pharma batch release. Mareana replaces manual rules and fragmented workflows with AI-powered, review-by-exception, purpose-built for QA teams.
Generic OCR / RPA
- Manual rules, basic pattern matching
- Threshold-based alerts only
- Log files + manual documentation
- Email & PDF workflows, fragmented approvals
- Static rules, manual updates
- Add-ons required, partial compliance
Mareana Batch Review Copilot
- Pharma-specific validation with calculations
- AI detects out-of-trend patterns with confidence scoring
- Full traceability: value → rule → verdict → e-signature
- Centralized, GxP-compliant approval workflows
- Learns from reviewer input under validation control
- Native 21 CFR Part 11 & GxP compliance
21 CFR Part 11 Audit Trails for
Every Validation Decision
Every validation is logged with source data, rules, reviewer actions, and e-signatures—fully audit-ready for global Pharma-CDMO collaboration.
Validation Decision Flow
Asset ID: asset-05-dual-approval-workflow
Complete Traceability
Trace any release decision back to source data in seconds.
Dual Approval Workflows
Role-based routing ensures accountable and compliant approvals.
Immutable Audit Trails
Immutable graph edges prevent retroactive modification.
Retraining Under Control
Log training datasets and model versions to prevent 'black box' drift.
Enterprise Integration with LIMS, ERP, and Batch Record Systems
Batch Review Copilot integrates with existing LIMS, ERP, and electronic batch record systems. Automated status updates keep processes aligned across systems and maintain uninterrupted workflow execution.
Plug into your existing LIMS, ERP, and MES — no workflow disruption
Frequently Asked Questions
Answers to common questions about Mareana, integrations, and compliance.
Exception-based review requires an Al rule engine that automatically validates all parameters-ranges, signatures, calculations, and open deviations-against specifications. The system flags only non-conformances for human attention, eliminating 100% manual review while maintaining full GxP traceability and 21 CFR Part 11 compliance through immutable audit trails.
Mareana utilizes industry-specific AI models trained on life sciences documentation to achieve over 99% accuracy, even with low-resolution scans and complex layouts.
Yes, our advanced OCR and handwriting recognition capabilities are specifically optimized for manual entries and annotations commonly found in paper-based batch records.
Our platform is enterprise-ready and highly scalable, capable of processing hundreds of thousands of pages per month with consistent performance and reliability.
Need More Information?
Connect with our experts to see how Review Copilot can streamline your batch validation and decision workflows.
Ready to Reduce Batch Review Time up to 70%?
Mareana Batch Review Copilot flags only what needs attention, so your QA team moves faster without compromising compliance.
