DOT Compliance

Dot Compliance is an electronic quality management system (eQMS) for life sciences companies, built natively on the Salesforce platform. It manages the regulated quality processes that pharmaceutical, biotechnology, medical device and cosmetics manufacturers must document and defend: document control, training, change control, quality events, CAPA, complaints, supplier quality, audits, equipment, risk and electronic batch records. The vendor describes it as the industry's first AI powered eQMS. It suits quality, regulatory and manufacturing teams that want prebuilt workflows rather than a configuration project. The platform ships with ready to deploy processes aligned to 21 CFR Part 11, ISO 13485 and cGMP, and its eleven core modules cover document, training, change, complaint, quality event, CAPA, supplier quality, audit, equipment, electronic batch record and risk management. The AI layer is Dottie, an assistant the vendor says is the first trained specifically on quality management workflows; it acts as a personal quality guide that helps users work through processes, strengthen quality practice and reduce cost and risk. Because the product is 100 percent native to Salesforce, no separate Salesforce license is required; everything needed is included. Pricing is not published. Dot Compliance offers a demo and a free trial through its website, and commercial terms are provided on request.