Dot Compliance QMS

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Streamline Quality with AI-Powered eQMS Software. Dot Compliance’s AI-powered eQMS solutions are built on the Salesforce platform and deliver 100% native Salesforce compliance. Salesforce supports more than 100,000 organizations and 220,000 deployed apps providing unmatched flexibility, consistent user experience, operational efficiency, data integrity and security, and scalability. Dot Compliance’s eQMS is designed to accelerate safe innovation across the life sciences, with ready-to-deploy process coverage and best practices at your fingertips. It is fully compliant with 21 CFR part 11, EU Annex 11, and supports ISO 9001, 13485, 14971, and 27001. ▶ Document Management: Capture, track, and store all your documents in one place. Dot Compliance’s document management solution is built on industry best practices ensuring compliance with global regulations and standards. Our cloud-based integrated software solution allows life sciences manufacturers to manage the entire life cycle of documents and content. ▶ Training Management: Simplify compliance with integrated training management. Manage end-to-end employee training from record management, course distribution and completion, and escalation. Organize training tasks, monitor status, improve employee efficiency, and enhance organizational accountability so you can stay compliant. ▶ Complaint Management: Manage, track, analyze, and address complaints quickly. Ready-to-use complaint handling helps ensure regulatory compliance, enhances product development, mitigates risk, and enables organizations to find opportunities for growth and innovation by meeting specific customer requirements. ▶ Change Management: Manage change at every level across your enterprise. Dot Compliance change management provides a standardized process for workflow flexibility, allowing a life sciences manufacturer to manage all types of changes from one centralized platform. ▶ CAPA: Streamline your corrective and preventive action (CAPA) process. Dot Compliance automates the process to help you quickly identify areas where a CAPA is needed and to prevent those issues from recurring. It includes integration with other core quality processes such as audit management, training management, document management, change management, and more. ▶ Risk Management: Take control over organizational risks today. A proactive, risk-based approach to managing quality minimizes the chances of adverse events and ensures continual improvement by predicting potential problems before they occur. ▶ Quality Events/Deviations/Nonconformance Management: Get end-to-end quality event management. Dot Compliance’s AI-powered, fully validated eQMS provides organizations with the ability to manage quality events so they are identified and recorded. This includes nonconformances, deviations, or incidents that could affect the quality or the reliability of records or tests to be investigated and resolved. ▶ Supplier Quality Management: Extend your quality system to your supplier ecosystem. With Dot Compliance’s supplier quality management solution, you can manage, track, and collaborate with suppliers, contract manufacturers, and distribution chain partners across the entire supply chain through one connected quality system.