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Automate Pharmaceutical COA Verification & Vendor Scoring with AI Document Analysis

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Created by: Oneclick AI Squad || oneclick-ai

Oneclick AI Squad

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Last update 2 days ago

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This enterprise-grade n8n workflow automates the Pharmaceutical Raw Material COA Verification & Vendor Quality Scoring System — from upload to final reporting — using AI-powered document extraction, specification matching, and dynamic vendor scoring. It processes Certificates of Analysis (COAs) to validate compliance, assign quality scores, generate approvals or CAPA requests, and notify stakeholders, ensuring regulatory adherence and vendor accountability with full audit trails and zero manual data entry.

Key Features

  • Webhook-triggered COA Upload for seamless integration with file-sharing systems
  • AI Document Extraction to parse test results and data from uploaded COAs
  • Automated Specification Analysis matching against predefined quality standards
  • Weighted Vendor Scoring based on compliance metrics and historical performance
  • Compliance Decision Engine with approve/reject branching and CAPA flagging
  • Dynamic Certificate Generation for approved materials, including digital signatures
  • Vendor Database Synchronization to update scores and records in real-time
  • Targeted Email Notifications for QA, production, and executive teams
  • Executive Reporting Dashboard with summaries, scores, and verification logs
  • Audit-Ready Logging for all steps, deviations, and decisions

Workflow Process

Step Node Description
1 START: Upload COA Webhook trigger receives uploaded COA file for verification process
2 EXTRACT: Parse COA Extracts test results and data from the COA document using AI parsing
3 ANALYZE: Vendor Compliance Compares extracted data against specifications and flags deviations
4 SCORE: Vendor Quality Rating Calculates weighted compliance score based on test results and history
5 DECISION: Compliance Route Evaluates score/status: Branches to approve (green) or reject (red) path
6 APPROVED: Generate Approval Cert (Approved Path) Creates digital approval certificate for compliant materials
7 Update Vendor Database Saves verification record, score, and status to vendor database
8 NOTIFY: Email Alert Sends detailed notifications to QA/production teams
9 REPORT: Final Report Generates executive summary with COA scores and verifications
10 REJECT: Generate Rejection Report (Reject Path) Produces rejection report with deviation details
11 Request CAPA Initiates Corrective and Preventive Action (CAPA) process
12 PATH REJECTED Terminates rejected branch with audit log entry

Setup Instructions

1. Import Workflow

  • Open n8n → Workflows → Import from Clipboard
  • Paste the JSON workflow

2. Configure Credentials

Integration Details
File Storage (e.g., Google Drive/AWS S3) API key or OAuth for COA upload handling
AI Extraction (e.g., Claude or OCR Tool) API key for document parsing (e.g., claude-3-5-sonnet-20241022)
Database (e.g., PostgreSQL/Airtable) Connection string for vendor records and specs
Email (SMTP/Gmail) SMTP credentials or OAuth for notifications

3. Update Database/Sheet IDs

Ensure your database or Google Sheets include:

  • VendorDatabase for scores and history
  • Specifications for quality standards

4. Set Triggers

  • Webhook: /coa-verification (for real-time file uploads)
  • Manual/Scheduled: For batch processing if needed

5. Run a Test

Use manual execution to confirm:

  • COA extraction and analysis
  • Score calculation and branching
  • Email notifications and report generation (use sample COA file)

Database/Sheets Structure

VendorDatabase

| vendorId | coaId | score | complianceStatus | lastVerified | deviations | capaRequested |
|--------------|-------------|----------|--------------------|--------------------|--------|--------------------|---------------|
| VEND-123456 | COA-789012 | 92.5 | Approved | 2025-11-04T14:30:00Z | None | No |

Specifications

| materialType | testParam | specMin | specMax | weight |
|--------------|-------------|----------|--------------------|--------------------|--------|--------------------|---------------|----------|
| API Excipient | Purity (%) | 98.0 | 102.0 | 0.4 |

System Requirements

Requirement Version/Access
n8n v1.50+ (AI and database integrations supported)
AI Parsing API claude-3-5-sonnet-20241022 or equivalent OCR
Database API SQL connection or Google Sheets API
Email API https://www.googleapis.com/auth/gmail or SMTP
File Storage AWS S3 or Google Drive API access

Optional Enhancements

  • Integrate ERP Systems (e.g., SAP) for direct material release
  • Add Regulatory Export to PDF/CSV for FDA audits
  • Implement Historical Trend Analysis for vendor performance dashboards
  • Use Multi-Language Support for global COA extraction
  • Connect Slack/Teams for real-time alerts beyond email
  • Enable Batch Processing for high-volume uploads
  • Add AI Anomaly Detection for predictive non-compliance flagging
  • Build Custom Scoring Models via integrated ML tools

Result:
A fully automated quality assurance pipeline that verifies COAs, scores vendors, and drives compliance decisions — ensuring pharmaceutical safety and efficiency with AI precision and complete traceability.

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