Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development
This white paper describes how compliance can be “hardwired” into the product development processes with a validated system that automatically captures required records for regulatory purposes. In addition, how such a system improves performance of several critical business processes including regulatory compliance, quality systems management, detailed design, change management, and requirements management will be covered. Lastly, an overview of PTC’s Product Development System, which helps leading medical device manufacturers to automate compliance and gain a competitive advantage will be provided.