§170.315(g)(4) Quality Management System

(g)(4) Quality Management System (QMS) is a set of policies, processes, and procedures required for planning and executing in the core business area of an organization (that is, areas that can impact the organization’s ability to meet customer requirements). All certified products are required to adhere to this requirement. Mirth® Connect uses CFR 21 Part 820, a recognized federal government QMS, in the development, testing, implementation, and maintenance for all certified criteria.

Mirth® Connect is certified to meet the (g)(4) Quality Management System requirement.