Dot Compliance

What it does

Dot Compliance is an AI-powered eQMS for life sciences quality management. It runs on the Salesforce platform and includes Dottie, an AI assistant trained on quality management workflows. It is built for pharmaceutical, biotechnology, and medical device teams that need to manage compliance and stay inspection ready.

Dot Compliance is a quality management system for life sciences teams. It runs on the Salesforce platform and the company says you do not need a separate Salesforce license. The platform covers document management, training, change, complaint, quality event, CAPA, supplier quality, audit, equipment, electronic batch record, and risk management. Dottie is an AI assistant trained on quality management workflows. The company states that all solutions come with full validation packages and meet 21 CFR Part 11 and EU Annex 11. It also says the platform is modular, so you can start with what you need and add more over time. The site lists ISO/IEC 42001, ISO 9001, ISO/IEC 27001, GAMP 5, ISO/IEC 27017, 21 CFR Part 820, ISO 13485, ISO 14971, 21 CFR Part 210, 21 CFR Part 211, and cGMP, cGDP, GCP. A free trial is offered. Pricing is not published. No public API documentation is shown on the page.