eQMS

Dot Compliance eQMS is an AI-powered Electronic Quality Management System purpose-built for the life sciences industry. Designed for pharmaceutical, biotechnology, and medical device organisations, it delivers a ready-to-deploy solution that streamlines quality processes, ensures regulatory compliance, and scales alongside growing business needs — all without lengthy design or configuration cycles.

As the industry's first AI-powered eQMS, Dot Compliance combines deep domain expertise in life sciences quality and compliance with a platform engineered to get teams up and running fast. Hundreds of life sciences organisations rely on it to drive quality efficiently, accelerate innovation, and stay ahead of compliance challenges.

Core Platform Capabilities

• Ready-to-deploy eQMS with unmatched off-the-shelf process coverage, eliminating lengthy design and configuration processes
• Dozens of pre-built modules and pre-validated packages configured with industry best practices to save time and resources
• Built natively on the Salesforce platform, delivering 100% native Salesforce compliance for flexibility, consistent user experience, operational efficiency, data integrity, security, and scalability
• Scalable architecture that grows from core quality processes to advanced AI-driven quality and compliance as organisations expand

AI-Powered Quality with Dottie

• All Dot Compliance eQMS solutions include Dottie, the industry-first AI quality and compliance guide
• Provides intelligent, proactive guidance to accelerate quality processes and tighten controls
• Helps organisations stay ahead of quality issues before they escalate
• Enables data-driven decision-making across quality and compliance functions

Industries Served

• Pharmaceutical — ready-to-use process coverage aligned with pharma quality requirements
• Biotechnology — best practices built in to support biotech innovation and compliance
• Medical Devices — purpose-built support for device quality management and regulatory requirements

Global Compliance Standards Supported

• ISO/IEC 42001 (AI Management Systems)
• ISO 9001 (Quality Management Systems)
• ISO/IEC 27001 (Information Security Management Systems)
• ISO/IEC 27017 (Cloud Security)
• GAMP 5 (Good Automated Manufacturing Practice for GxP Systems)
• 21 CFR Part 820, ISO 13485, and ISO 14971 for Medical Devices
• 21 CFR Part 210, 21 CFR Part 211, cGMP, cGDP, and GCP for Pharma and Biotech

Dot Compliance eQMS is deployed on the Salesforce platform, supporting the same infrastructure trusted by more than 100,000 organisations and 220,000 deployed apps worldwide. This foundation ensures enterprise-grade security, scalability, and a familiar user experience, making it a robust choice for life sciences organisations seeking a compliant, future-ready quality management solution.