Dot Compliance was established in 2016 after evolving from a life science consulting firm that had been observing the challenges of implementing an electronic quality management system for life sciences. Modern quality is fragmented, with at least 50% of life science organizations still using risky and inefficient paper-based QMS or disconnected processes. With so many disparate processes across any given organization as well as evolving industry regulations, life sciences are overwhelmed by having to keep up with the speed of complex quality management.
A QUALITY MANAGEMENT SYSTEM IS A FORMALIZED SYSTEM THAT DOCUMENTS THE POLICIES, PROCEDURES, DOCUMENTATION REQUIREMENTS, AND PROCESSES THAT MEDICAL DEVICE COMPANIES USE TO ENSURE THAT THEIR PRODUCTS ARE BOTH SAFE AND EFFECTIVE FOR THE END USER.
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