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Automated GxP Reporting and Data Synchronization System

appsilon.com

Medical

Pharmaceuticals

Biotechnology

Challenges in Manual Reporting and Data Synchronization

The client faces inefficient, manual GxP document generation processes prone to human error, with report creation taking 5 weeks. Data synchronization issues in critical reports (CPV, APR, Stability Testing) risk partial/incorrect outputs, requiring 3 months for resolution. Compliance with GxP standards and audit-readiness are compromised.

About the Client

A research-focused biopharmaceutical company developing lifesaving medicines with strict adherence to regulatory compliance standards.

Key Project Goals

Automate 85%+ of GxP document generation workflows
Reduce report generation time from weeks to minutes
Implement real-time data synchronization monitoring
Ensure compliance with GxP/GMP standards
Achieve $1M+ cost savings over 3 years

Core System Functionalities

Automated CPV, APR, and Stability Testing report generation (Word/PDF with 20+ attachments)
Real-time alerting system for data synchronization issues
Modular investigation tools for root cause analysis
Interactive, compliant UI/UX for data visualization
Audit-ready logging infrastructure with extended retention

Technology Stack

R Shiny

JavaScript

CSS

GIT

Posit Package Manager

System Integrations

Jenkins
GitHub Actions
Existing GxP data infrastructure

Non-Functional Requirements

High availability for compliance-critical workflows
Scalable architecture for 500+ users
Real-time performance (sub-5-minute report generation)
Data security and audit trail compliance
Modular design for agile updates

Expected Business Impact

Projected $1M+ cost savings over 3 years through automation, 99.9% reduction in report generation time (5 weeks → 5 minutes), 99.7% faster data sync issue resolution (3 months → 1 day), 230% user growth (150 → 500), and enhanced audit-readiness with automated compliance checks.