What is Dot Compliance?
Dot Compliance provides the industry's first AI-powered electronic Quality Management System (eQMS) built specifically for life sciences organizations. The platform is designed to accelerate innovation, streamline quality processes, and ensure compliance with regulations such as 21 CFR Part 11, EU Annex 11, and support for ISO standards.
Built on the Salesforce platform, Dot Compliance offers a ready-to-deploy eQMS solution with pre-built and pre-validated processes, promoting faster implementation and reduced IT risk. The system, featuring 'Dottie' the AI assistant, supports various quality management processes including document management, change management, audit management, and risk management, helping companies improve efficiency and make data-driven decisions.
Features
- Ready-to-deploy eQMS: Pre-built and pre-validated, incorporating industry best practices and key workflows.
- Salesforce Platform: Delivers 100% native Salesforce compliance, flexibility, and scalability.
- Dottie AI Assistant: Specifically trained on quality and compliance workflows for enhanced process efficiency.
- Document Management: Streamlines the creation, review, approval, and control of quality documents.
- Change Management: Manages and controls changes to processes, documents, and systems.
- Audit Management: Facilitates internal and external audits, ensuring compliance.
- Training Management: Tracks and manages employee training records and requirements.
- CAPA Management: Streamlines corrective and preventive actions.
- Risk Management: Identifies, assesses, and mitigates quality and compliance risks.
Use Cases
- Accelerating product launches in pharmaceutical companies.
- Streamlining regulatory compliance in biotechnology firms.
- Improving quality control in medical device manufacturing.
- Managing and controlling documents across life sciences organizations.
- Implementing and tracking corrective and preventive actions (CAPA).
- Facilitating internal and external audit processes.
- Managing changes in processes, systems and documentation.
- Ensuring compliance with 21 CFR Part 11, EU Annex 11 and support for ISO 9001, 13485, 14971 and 27001.
