Question: How does Dot Compliance handle customizing workflows such as Lot History Records (LHRs) or Change Control?
Mickey Landkof: Dot Compliance solutions come out of the box ready to use with best practices and industry standards setup including a plethora of workflows that are preset. This out of the box setup is also completely pre-validated. With that said, the setup is not ‘hard coded’ allowing for customizations of workflows as needed. This is done by point and click type of configuration work/setup that can be done by an administrator of the system.
Question: Is there customization to reporting to account for business KPIs that calculate across Quality data?
Mickey Landkof: The Dot Compliance system comes with pre-built reports and dashboards. However, users can customize their reports and KPIs to address their specific requirements using the built-in reporting tool. Such setup is conducted by a point-and-click configuration setup approach. The system will calculate KPIs for any of the Quality Data that is available in the system.
Question: For someone completely new to the med device space looking to bring a class I device to market, would this system be ideal for them? The worry is that a system will be in place, but no real direction on how to use it to its full potential (and required potential by the FDA).
Mickey Landkof: We offer a complete solution, based on best practices, but we also can provide lots of guidance if needed. We have a comprehensive knowledge base and also have sample SOPs. If needed, we have partners that focus specifically on helping medical device companies. In areas where our turf ends, we can bring others in.
Question: Is Dot Compliance similar to Greenlight Guru? How does it differ?
Mickey Landkof: I’ve been in the QMS space for 15 years, having worked for other vendors out there. I know all the players quite well, including Greenlight Guru. There are differences for sure. They have their own technology. We leverage different types of tech with Salesforce that brings to the table a great deal of innovation. Our solutions are ready to use which allow customers to get up and running very quickly and cost effectively. So there is typically a much shorter time to implement and approximately 20-30% lower cost of ownership