Device Master Record Management

Device Master Record Management includes these capabilities:

• Manages part effectivity and disposition checks.
• Provides audit trails and authentication controls for every step in the design and release process.

Device Master Record Management provides an integrated system to manage all elements of the Device Master Record (DMR) within accordance of the U.S. Food and Drug Administration's (FDA's) Quality System Regulation (QSR) and ISO standards. It provides full audit trails and powerful authentication controls for FDA Part 11 compliance. Device Master Record Management manages communication and process collaboration among your product development team's design engineers, manufacturing engineers, software engineers, and suppliers.