Dot Compliance

Dot Compliance is a web-based, AI-powered electronic Quality Management System (eQMS) for life sciences organizations, including pharmaceutical, biotech, and medical device companies.

Key capabilities include:

• Dottie AI quality assistant (generative and predictive), trained on quality and compliance workflows to provide intelligent insights, recommendations, anomaly detection, and regulatory risk flagging
• Vendor-agnostic decision guidance that analyzes quality data across multiple systems to identify risk and monitor against reference scenarios
• Ready-to-deploy, pre-configured and pre-validated processes (including QMS Xpress and Xpand) designed to reduce implementation effort while supporting inspection readiness
• Process coverage for core QMS workflows, including document, change, audit, training, CAPA, complaint, risk, supplier quality, equipment management, and electronic batch record

Pricing is not publicly specified.

Notable for combining a Salesforce-native platform with a purpose-built AI assistant (launched April 2023) and packaged validation support aligned to standards such as 21 CFR Part 11, EU Annex 11, and ISO frameworks (including ISO 9001, ISO 13485, ISO 14971, and ISO/IEC 27001), targeting faster time to value for regulated quality teams.