Primed to revolutionize quality management and compliance for the life sciences industry, Dot Compliance’s ready-to-use generative and predictive AI automation increases efficiency and higher quality outcomes in compliance, documentation, and reporting. This results in products that are accelerated to market and future-proofed against the evolving life science landscape.
[Phoenix, Arizona, April 4, 2023] – Dot Compliance, a leading provider of eQMS compliance solutions for the life sciences sector, has introduced an industry-first, ready-to-use AI-Based electronic Quality Management System for life sciences, powered by an embedded generative and predictive artificial intelligence. The system deploys ChatGPT combined with proprietary algorithms to optimize quality processes, automate tasks and help professionals working in quality assurance to focus on what really matters while enhancing the compliance of their organizations.
Over the last three 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.
“It is like having a quality assurance specialist by your side, at all times. The augmented use of AI is broadening horizons for the personnel in the quality arena and is unparalleled in terms of productivity and speed. The Life Science industry has quite rightfully a meticulous, yet painstaking process for stewarding new products to market. This process must remain as safe and detailed as is required, but it can be made exponentially more efficient. Dot Compliance has embedded advanced AI capabilities with QMS, building a level of insight that is so far unrivaled. We are the first company to introduce generative AI to the quality and compliance space in this way,” said Doron Sitbon, Founder & CEO at Dot Compliance.
Quality management is a mission critical activity for pharmaceutical and medical device organizations. Failure to implement effective quality management measures to ensure the safety and efficacy of products result in a range of undesirable consequences, such as product recalls, regulatory fines, legal liabilities, damage to brand reputation, and harm to patients.
“There is a wealth of untapped potential for innovation in quality management regarding compliance, and Dot Compliance has shown leadership in this space. Its ready-to-use AI capabilities via the eQMS accelerates our use of Dot Compliance’s solution, and will drive internal discussions on the many ways we can use it, creating more spare time for our teams they would have used managing quality events, and a platform to gain knowledge and understanding of quality processes much faster,” said Amir Malka, Chairman and CEO of BioForum
“The release of this generative AI solution is a significant milestone in the transformation of Dot Compliance’s vision to lead the quality and compliance AI space, offering tremendous value to customers and other stakeholders,” said Haim Shani, Founder and General Partner at IGP Capital – which led Dot Compliance’s recent B series.
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.
Through Dot Compliance’s solution, manufacturers can seamlessly integrate AI-driven quality management systems into their existing processes and benefit from an AI platform that constantly learns – enhancing its performance over time and providing increasingly accurate insights and predictions. The technology improves overall efficiency of quality management processes, enabling faster product development, approval, and market launch, while minimizing the risks associated with costly regulatory penalties, recalls, and reputational damage. With hundreds of customers globally, and tens of thousands of users, Dot Compliance’s cost-effective and AI-powered QMS solution helps the life science industry reach millions of patients, who would otherwise be left waiting.
About Dot Compliance
Founded in 2015, Dot Compliance offers the industry’s first ready-to-use Quality Management System powered by the Salesforce.com platform. The Dot Compliance Suite includes an extensive set of off-the-shelf ready QMS and compliance pre-configured best practice processes, enabling customers to deploy quickly and cost effectively. The company’s solutions are trusted by life sciences companies, both large and small, worldwide with tens of thousands of users. The solutions are fully compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14791 and 27001. Headquartered in Phoenix, Arizona, Dot Compliance was founded in 2015 by Doron Sitbon. Dot Compliance currently employs over 100 professionals across the world.. For more information, visit https://www.dotcompliance.com/.