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Integrated Logistics and Quality Management System for Biomedical Operations

limestonedigital.com

Medical

Biotechnology

Pharmaceuticals

Operational Inefficiencies in Biomedical Production

Manual logistics management and quality control processes led to human errors, slow workflows, and compliance risks in vaccine/medicine production requiring 100% accuracy. Existing systems lacked automation for measurement conversions, recipe validation, and inventory tracking.

About the Client

Molecular biology specialist company producing real-time PCR-based tests and developing serums/vaccines

Key Project Goals

Automate complex calculation workflows with 100% accuracy
Reduce manual data entry errors by 90%
Implement real-time inventory tracking with expiry date monitoring
Ensure compliance with biomedical quality standards (ISO 13485, FDA 21 CFR Part 820)
Decrease operational training time by 75%

Core System Requirements

Recipe management with version control and formula validation
Interactive laboratory simulation environment
Multi-unit measurement conversion engine
Dynamic inventory catalog with smart filtering
Real-time quality control dashboard with audit trail
Customizable reporting with export capabilities

Technology Stack

React

.NET Core

System Integrations

Laboratory equipment APIs
Enterprise Resource Planning (ERP) systems
Electronic Lab Notebook (ELN) platforms

Non-Functional Requirements

256-bit AES data encryption for HIPAA/GDPR compliance
99.9% system availability with failover architecture
Sub-second response time for critical operations
Role-based access control (RBAC) with multi-factor authentication

Expected Business Impact

Projected 12% reduction in operational time consumption and 3% increase in daily lab throughput through automated workflows, with elimination of 95% of manual calculation errors. Compliance automation expected to reduce audit preparation time by 40%.