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Comprehensive Quality Assurance Modernization for Regulated Industry Software
  1. case
  2. Comprehensive Quality Assurance Modernization for Regulated Industry Software

Comprehensive Quality Assurance Modernization for Regulated Industry Software

coherentsolutions.com
Life Sciences
Medical
Pharmaceuticals

Identifying the Challenges in Regulated Industry Quality Management Systems

A leading provider of enterprise quality management software faces complex integration challenges, performance bottlenecks, and security vulnerabilities when managing large-scale document processing and compliance-driven workflows across multiple products and clients. Manual data extraction and outdated processes increase risks of non-compliance and operational inefficiencies.

About the Client

A large enterprise specializing in enterprise quality management software tailored for industries with strict regulatory compliance standards, seeking to enhance system performance, security, and user experience.

Transforming Quality Assurance with Scalable and Secure Technology Solutions

  • Implement over 100 new functional features to enhance system capabilities.
  • Design and deploy more than 25 architectural solutions to improve system robustness and scalability.
  • Achieve a 2.5x increase in the performance of key system components.
  • Streamline document processing and workflow automation to reduce manual effort and increase efficiency.
  • Enhance security protocols to meet regulatory standards for sensitive data management.
  • Improve user experience through advanced document management, search, and automated rule-based functionalities.

Core Functional System Capabilities for Quality Management Transformation

  • Document grouping and bulk action processing for workflows, ownership transfer, and metadata management.
  • Configurable system rules for automatic default value assignment based on regulatory and business parameters.
  • High-performance search engine supporting keyword queries within multi-gigabyte document content.
  • Version comparison tools for identifying changes between document iterations.
  • Automated data extraction and statistical reporting for product reviews, reducing manual effort and ensuring compliance.
  • AI-powered text cleansing and classification using NLP techniques for improved data accuracy and issue resolution.
  • Performance monitoring and metrics dashboards for proactive system health management.

Preferred Architectural Technologies and Platforms

Cloud scalability leveraging AWS or similar cloud platforms
Advanced search engine technologies like Elasticsearch
NLP frameworks for text classification and cleansing
Microservices architecture for modularity and flexibility
Security standards aligned with industry regulations

Necessary External System Integrations

  • External document storage and management systems
  • Business process automation tools
  • Regulatory compliance and data auditing platforms
  • Performance monitoring and analytics services

Non-Functional System Requirements

  • System performance optimized for processing millions of documents with up to 3,000,000 characters and 2GB per document
  • High system availability and reliability
  • Robust security measures including data encryption and access controls
  • Scalability to support expanding client bases and increasing data volumes
  • Automated monitoring and alerting for issue detection

Expected Business Benefits of QA Modernization Initiative

The project aims to deliver significant operational efficiencies, including a 2.5x performance increase in core components, over 100 new features, and more than 25 architectural improvements. It will reduce manual data processing durations, minimize compliance risks, and enhance user productivity, ultimately strengthening the client’s market position and ensuring sustained compliance excellence.

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