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Quality is at the heart of the highly regulated lifesciences industry. Ever changing regulations and technology are improving the quality of life, though often increasing the complexity of managing business processes. The Quality System requirement for this industry is very stringent. To maintain a robust, flexible and compliant integrated quality management system, quality issues needs to be tracked, managed proactively and resolved quickly.
Qualityze, the next generation quality management software solution for Lifesciences is built on the Salesforce.com platform. A cutting-edge enterprise cloud platform with flexibility, ease of use, risk mitigation and compliance enabled. The solution provides you with a closed loop EQMS system that enables you to be compliant with internal and external regulations. Qualityze enables you to comply with US FDA (21 CFR part 11, 21 CFR part 820), ISO 13485 standards, Pharmaceuticals and Medical Devices Agency (PMDA), and Therapeutic Goods Administration (TGA).
The Qualityze EQMS solution is a closed-loop quality system which includes,
- Document Management
- Change Management
- Nonconformance Management
- CAPA Management
- Audit Management
- Training Management
- Complaint Management
- Supplier Management
- Audit Trail
- Electronic Signature
- Dashboards, Reports and Analytics