Dot Compliance QMS

What Dot Compliance QMS is

Dot Compliance QMS is an electronic quality management system for life sciences organizations. Its workflows cover document, training, complaint, change, CAPA, risk, quality event, supplier quality, equipment, regulatory, and audit management. The product is built natively on Salesforce, and the company describes it as a pre-validated solution with validation documentation for customers. Salesforce also enables connections with customers’ existing data sources and processes. Electronic signatures include multi-factor authentication, signature meaning, and a permanent time-stamped audit trail. Dot Compliance says the QMS supports requirements including 21 CFR Part 11, EU Annex 11, ISO 9001, ISO 13485, and ISO 14971. Its AI assistant, Dottie, is described as trained on quality management workflows. Mobile resources include a Salesforce for Mobile user guide, while the Help Center also provides manuals, video tutorials, webinar materials, and tips. The company says it has supported life sciences companies since 2015 and has more than 500 customers across 30 countries. The software is paid, has no free plan, and pricing is available on request; a demo is offered.