Quality Management Solution (QMS) 

Business Challenge

Organizations need to assure product quality to their partners, regulators and customers. This requires a robust quality management solution embeded within their Product Lifecycle Management (PLM) systems.

The Solution

Increasingly, medical device and drug manufactuteres are looking to deploy solutions that adhere to Good Automated Manufacturing Practices (GAMP) and esure quality at each stage of the manufacturing process. Systems capable of providing electronic signoffs, record retentions and digital archives for Quality Documentation and Control on the Standard Operating Procedures (SOPs) are essential for processes that can affect the quality of the finished product. Realizing this need, Datafrond developed a business ready, preconfigured and packaged Quality Management solution (QMS) that contains end-to-end best practices in quality management business processes.

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Solution Features and Offering Details

• QSOPs – Quality Document Release Management and Change Control
• Corrective Actions and Root Cause Analysis (CAPA)
• Audits & Management Controls
• Training Module
• Inspections & Nonconformance (NC) & Deviations
• Equipment & Calibration Logs
• Customer Complaints and Adverse Event Reporting
• Software Validation
• Regulatory Submission

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