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Modernizing Quality Assurance Systems for Regulated Industries
  1. case
  2. Modernizing Quality Assurance Systems for Regulated Industries

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Modernizing Quality Assurance Systems for Regulated Industries

coherentsolutions.com
Medical
Life Sciences & Biotech
Healthcare

Challenges in QA Modernization for Regulated Sectors

Need for a strategic partner to handle complex integrations, improve system performance by 2.5x, enhance security, and modernize SDLC processes while maintaining backward compatibility for 100+ clients. Manual data extraction from silos caused 3-month delays in annual reviews with compliance risks.

About the Client

Leading global provider of enterprise quality management software for regulated industries

Strategic Modernization Goals

  • Develop 25+ architectural solutions for seamless upgrades
  • Implement performance improvements in critical components
  • Automate regulatory compliance through rule-based configurations
  • Integrate AI-powered text classification for issue resolution
  • Establish scalable document management with bulk actions

Core System Requirements

  • Bulk document actions (workflow progression, ownership transfer)
  • Rule-based metadata automation for regulatory compliance
  • Advanced search engine for multi-GB document repositories
  • Statistical packages for automated annual product reviews
  • NLP-powered text cleansing and classification service

Technology Stack Requirements

AWS
Salesforce
NLP
AI
Cloud Migration

System Integration Needs

  • Salesforce-AWS ecosystem integration
  • Legacy document management systems
  • External data silos for regulatory reporting
  • Electronic forms management platform

Operational Requirements

  • Enterprise-grade security compliance (HIPAA, GDPR)
  • 99.99% system availability SLA
  • Scalable architecture for 3M+ document processing
  • Real-time monitoring dashboard
  • Backward compatibility for 100+ client implementations

Expected Business Outcomes

2.5x performance improvement in critical components, 80% reduction in annual review production time, 30% cost savings through automation, and 95%+ accuracy in regulatory compliance configurations. Enhanced ability to manage 100M+ documents annually with automated version control and metadata management.

More from this Company

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Transformation to Software Platform Provider with Enhanced QA and User Experience