CHALLENGE
A centralized Quality Management System
A global pharmaceutical and diagnostics client needed to develop and maintain a centralized Quality Management System (QMS) to comply with local and global regulatory requirements.
The system needed to facilitate the registration, tracking, and management of various quality processes, ensuring a standardized and efficient approach across all locations.
SOLUTION
Comprehensive system support
7N provided a dedicated development team to design, implement, and maintain the QMS, contributing to:
Standardizing quality processes
Unified multiple LTCM processes into a single GTCM system
End-to-end system configuration
Designed and implemented workflow automation for processes such as Local Change Control, CAPA, Complaints, Discrepancy, and Audits
System integration
Developed interfaces with existing enterprise systems, including SAP, EDMS, and MDMS, ensuring seamless data exchange
Process optimization & compliance
Conducted necessary risk assessments to create key regulatory documentation
Comprehensive testing & validation
Led System Unit Tests, System- and User Acceptance Tests to guarantee functionality and compliance
Continuous improvement & monitoring
Established KPIs to track efficiency and drive service improvements
IMPACT
Unified quality control
Automated workflows increased efficiency, reduced manual effort, and ensured consistent quality control across all locations. The team's high performance led to continued collaboration and contract extensions.
The unified Quality Management System helped the client:
Streamline global processes
Improve regulatory compliance
Enhanced system integration with enterprise tools
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