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Company description

Dot Compliance is an AI-powered electronic Quality Management System (eQMS) provider purpose-built for the life sciences industry. Founded in 2015, the company pioneered the industry's first ready-to-use eQMS and has since grown to serve more than 500 customers across 30 countries, helping pharmaceutical, biotechnology, and medical device organizations bring safe, high-quality products to market faster and more efficiently.

Built natively on the Salesforce platform, Dot Compliance delivers a pre-built, pre-validated eQMS that requires no separate Salesforce license and integrates seamlessly with ERP systems and other critical tools. The platform is designed for rapid deployment, lower total cost of ownership, and reduced IT risk, enabling life sciences teams to manage quality with confidence, maintain continuous compliance, and keep every process inspection-ready from day one.

Key Quality Management Modules

• Document Management – Centralized control of quality documents and records
• Change Management – Structured workflows for managing and tracking changes in regulated environments
• Quality Event Management – Capture, investigate, and resolve quality events efficiently
• CAPA Management – End-to-end corrective and preventive action tracking
• Audit Management – Plan, execute, and follow up on internal and external audits
• Training Management – Assign, track, and verify employee training and competency
• Complaint Management – Manage and resolve customer and product complaints
• Risk Management – Identify, assess, and mitigate quality and compliance risks
• Supplier Quality Management – Oversee supplier qualification and performance
• Equipment Management – Track and maintain equipment calibration and qualification
• Electronic Batch Management – Manage batch records electronically within a compliant framework

AI Capabilities — Meet Dottie

• Dottie is the industry's first AI assistant specifically trained on quality management workflows for life sciences
• Serves as a personal AI quality guide embedded within the eQMS platform
• Helps organizations strengthen quality processes, save time, and reduce organizational costs and risk
• Trusted by hundreds of life sciences organizations to support data-driven quality decisions
• Dot Compliance leads the use of safe, effective AI to accelerate innovation and build a culture of quality

Platform and Technology

• 100% native Salesforce platform, supporting unmatched flexibility, consistent user experience, data integrity, and security
• No separate Salesforce license required — everything needed is included
• Modular architecture allows organizations to start with core processes and scale over time
• Pre-configured and ready-to-deploy solutions enable rapid implementation without extensive customization
• Seamless integration with ERP systems and other critical tools via the Salesforce ecosystem
• Full validation packages included with all solutions

Compliance and Regulatory Standards

• Quality & Compliance: ISO/IEC 42001 (AI Management Systems), ISO 9001, ISO/IEC 27001, ISO/IEC 27017 (Cloud Security), GAMP 5
• Electronic Records: 21 CFR Part 11 and EU Annex 11
• Medical Device: 21 CFR Part 820, ISO 13485, ISO 14971
• Pharma & Biotech: 21 CFR Part 210, 21 CFR Part 211, cGMP, cGDP, GCP

Industries Served

• Pharmaceutical companies requiring GxP-compliant quality management
• Biotechnology organizations managing complex quality and compliance workflows
• Medical device manufacturers subject to FDA and ISO regulatory requirements

Company Highlights

• Founded in 2015 and headquartered with a global presence spanning 30 countries
• More than 500 life sciences customers worldwide
• Deep domain expertise across enterprise software, quality and compliance, and process optimization
• Team led by experienced executives including a Chief Data Scientist and dedicated VP of Product Management and R&D
• Committed to customer success, rapid time-to-value, and continuous innovation in AI-driven quality management

Dot Compliance empowers life sciences organizations of all sizes to build a culture of quality, accelerate safe innovation, and maintain inspection readiness — all through a scalable, AI-powered eQMS that delivers speed, security, and compliance from the moment of deployment.

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Software attributed to Dot Compliance Ltd.

• eQMSView
• Regulatory ManagementView
• EBRView

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