Case Study · Pharma & Healthcare

AI-Powered Batch Record Review — Platform Overview

Pharma · GMP-Compliant · 50+ AI Validation Checks · Azure/AWS-Native

The challenge

A slow, manual review cycle.

5–7 day review cycle

Average batch review cycle spans 5–7 days with 100–1,000+ pages reviewed manually per batch.

40%+ reviewer time on repetitive checks

QA reviewers spend the majority of their time on repetitive, rule-based page-by-page checks.

Human error & inconsistency

Inconsistent review quality across shifts and sites creates regulatory risk and QA burnout.

$50K+ cost per delayed batch

Delayed batch release directly impacts revenue and time-to-market for pharmaceutical manufacturers.

What we built

50+ AI agents for batch validation.

Intelligent OCR pipeline

TrOCR + Azure Document Intelligence for handwritten and printed content extraction with high accuracy.

50+ AI agents for validation

Automated rules engine covering signatures, parameters, yields, timing, reconciliation, and compliance.

4-step automated pipeline

Upload → Process → Validate → Report. Audit-ready dashboard with deviation flags and confidence scores.

6 validation categories

Signatures & Stamps, Process Parameters, Yield & Quantities, Sequential Timing, Environmental Data, Regulatory Fields.

Results

Quantified outcomes.

60–80%

Review time reduction across the QA workflow.

95%+

Check automation coverage.

300+

Products supported in production.

Multi-Site

Enterprise scalable across facilities.

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