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 (Designed-in Product and Process Quality)
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 (QLM-IN-A_BOX) that contains end-to-end best practices in quality management business processes.
Proven Industry Best Practices (Industrial & Medical Device Manufacturers).
Proven, cost efficient implementation methodology aligned to ISO 9001.
Computer Software Validation per ISO 13485 & 21 CFR Part 820.
Documented Business process with Software Validation Plan and Training Documentation (Per Medical Device ISO 13485 & 21 CFR Part 820).
Easily linked with PLM-IN-A-BOX solution for Design Control (CAD Data Management), Change Control, Supplier Collaboration
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