Doron Sitbon, founder and CEO of Dot Compliance (Linkedin)
Dot Compliance is an Israeli startup that offers AI-enabled Quality Management System (QMS) solutions. The firm raised $17.5 million in Series B extension funding, bringing its total funding to date to $50 million.
Founded in 2007, Dot Compliance delivers ready to use management software solutions designed specifically for the life science industry; medical devices, biotechnology, and pharmaceutical companies.
Over the last few years, the FDA, EMA and other regulators have issued over $100 million in fines to life sciences companies for violations related to quality and safety standards, and with the average cost of leading a new drug to market being over $2.6 billion, the losses incurred due to delays or mistakes can be colossal. Cutting through the complexity of regulatory demands takes a significant investment of time and manpower, which inevitably impacts the survival of a life science company, impedes the likelihood of drugs reaching shelves and ultimately, limits patient access to the right medicines and medical devices at the right time. The use of AI to make informed decisions and enforce good quality management practices (GMP) can reduce these costs.
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The Dot Compliance Suite includes an extensive set of fully pre-validated ready to use eQMS processes. QMS Xpress, the company’s flagship solution, is out of the box and ready to use, enabling customers to deploy quickly in a cost-effective way. Dot Compliance Xpand provides additional processes to support an organization’s growing quality needs.
Dot Compliance introduced the industry’s first ready-to-use QMS powered by the Salesforce.com platform in 2015 and launched the industry’s first eQMS with generative AI.
Dr. Yuval Nardi, Chief Data Scientist of Dot Compliance, said “We are in the midst of an AI revolution with major breakthroughs happening in the last couple of years. Dot Compliance is evolving into a data-centric company, significantly improving quality and compliance processes in the life sciences sector by introducing a groundbreaking, dedicated and fine-tuned AI data pipeline leveraging cutting-edge generative and predictive AI technologies. This provides our customers with timely, precise, and actionable AI-driven insights tailored to their specific use cases.”
