Automated Regulatory Authoring for Life-Critical Medical Documentation

Regulatory Intelligence

mRNAProduct DesignRegulatoryAutomationWeb App
Produced bySorcero
Regulatory Intelligence Interface
Overview

Designed an automated regulatory authoring platform for high-stakes medical documentation, including mRNA vaccine specifications and validation summaries. The system automates writing and data transfer across complex regulatory documents without sacrificing trust, traceability, or human approval.

Problem

Medical regulatory documentation is:

  • -Extremely dense and interconnected
  • -Manually copied across multiple source documents
  • -Zero tolerance for errors or ambiguity
  • -Existing tools treat these documents like text

They are structured systems with scientific constraints.

Goal

Design a platform that:

01Automates regulatory writing
02Preserves scientific authority
03Improves accuracy and review speed
04Makes every value traceable and auditable

Automation could assist, but never replace, human judgment.

Solution

Side-by-Side Authoring Workspace

Target document and source document shown simultaneously with synchronized navigation for fast verification and visual comparison of acceptable ranges vs actual values.

Side-by-Side Authoring Workspace
Tier 1 Document (Target)CX-239827 MRNA comparability Report v2.0
  • - 2.1 In Process Controls Table
  • - Residual Protein, mRNA Content, Bioburden
  • - Bacterial endotoxins, Filter Integrity
Source DocumentPV-VAL-RPT-0010 mRNA PPQ Verification Summary
  • - Table 11: mRNA In-Process Controls
  • - Table 12: Bioburden Summary
  • - Sample data across multiple lots
Data Layer

Structured Data Extraction

Values extracted as data, not text. Each value retains source document, table, and page reference enabling validation, reuse, and reviewer confidence.

Source Reference Tooltip
Traceability Example
Value6.6 mg/ml
Source DocPV-VAL-RPT-0010
PagePage 14
TableTable 11

Every data point maintains full provenance, allowing reviewers to verify source material with a single click.

Core Interaction

Approval-First UX

Every data point requires explicit human approval. Clear approved, pending, and rejected states with no silent automation.

Approval Context Menu

Contextual Actions

Approve, disapprove, inspect source, or replace at the cell level. Mirrors how scientists already review data.

ApproveAccept value and mark as verified
DisapproveReject value with reason tracking
Paste From ClipboardManual value override
InfoView full source context
Information Architecture

AutoWriter mRNA Documentation System

Regulatory System Architecture
Workflow Stages
  • - Source Documentation
  • - Tier 2 Documentation
  • - Tier 1 Documentation
  • - Data Extraction & SME Consolidation
Tool Performance
  • - Manual Time: 5-58 min
  • - Automated Time: 2-3 min
  • - Time Reduction: 60%-80%
  • - Data Accuracy: 100%
mRNA Process Parameters
  • - IVT Reaction
  • - Cap Reaction
  • - Oligo dT2 Chromatography
  • - Quality Controls
System Integration
  • - Nexus Storage
  • - OpenBio
  • - EBR System
  • - Automatic Generation
Visual System
  • - Clean, professional interface for regulatory workflows
  • - Light theme with blue/purple accents for trust
  • - Dense data tables optimized for scientific review
  • - Clear visual hierarchy between target and source
  • - Green checkmarks for approved, yellow for pending
  • - Contextual tooltips preserve focus

Color Palette

Background
Surface
Primary
Accent
Approved
Pending
Outcome
+Reduced manual errors and rework
+Faster regulatory authoring cycles
+Higher trust from scientific and QA teams
+Strong adoption in a domain typically resistant to automation
sadra targhi — regulatory intelligence case study
Next Project

The Clinic

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