Quality Management Solutions

Computer System Validation (CSV) is the process of ensuring your software system performs as intended and maintains data integrity and security. For FDA-regulated manufacturers, CSV is mandatory: it provides documented evidence that your system meets regulatory requirements, maintains audit trails, prevents unauthorized changes, and produces accurate results. Without proper CSV documentation, your system cannot pass FDA inspections. Strategic's validation expertise ensures your NetSuite or QAD implementation is audit-ready with comprehensive documentation, reducing inspection risk.

A Quality Management System (QMS) is integrated software and processes that manage quality from raw materials through distribution. It documents procedures, captures quality data, manages non-conformances, and enables traceability. Manufacturers use QMS to prevent defects, reduce waste, enable recalls, and demonstrate compliance to customers and regulators. A modern QMS integrated with your ERP provides real-time visibility into quality metrics, accelerates issue resolution, and builds customer confidence. For regulated industries, QMS is non-negotiable.

ISO 13485 (medical device QMS) requires documented procedures, training records, management review, and traceability. A NetSuite partner experienced in medical devices preconfigures quality workflows, document management, and audit trail capabilities aligned with these requirements. They integrate configuration with procedure documentation and ensure testing validates compliance controls. Strategic's implementation approach for medical device clients emphasizes regulatory validation and audit readiness from blueprint through go-live, reducing post-launch compliance risk.

Prepare by ensuring your ERP system has comprehensive audit trails documenting all transactions, especially for regulated products. Conduct internal audits of your QMS and manufacturing processes for gaps. Maintain current batch records, training documentation, and change management records. Verify your system validates equipment and processes per FDA guidance. Ensure all deviations are documented and investigated. A partner like Strategic can help audit your system readiness and address gaps before regulators arrive, strengthening your compliance posture.

Top QMS solutions for pharma include Veeva, ETQ (QMS), MasterControl, and Danaher's eMerge. Veeva leads for large pharma due to enterprise features and industry dominance. ETQ excels for mid-market companies with balanced functionality and implementation speed. The best choice depends on your company size, regulatory complexity, and integration needs with your ERP. Many pharma companies integrate ETQ QMS with QAD or NetSuite for unified operations and compliance visibility. Strategic can guide your QMS selection based on your specific requirements.