Greenlight Guru, a medical device quality management software (MDQMS) platform, has launched Quality Event Automation, providing quality teams the ability to automate their quality event processes through custom workflow templates and automated tasks to create efficiency and improve post-market quality management.
Medical device quality managers handle quality events by following defined processes and using various forms, flow diagrams and other documents. This manual process can increase the likelihood of missing important steps in the quality event process and force quality teams to manually rework each new quality event initiated.
Greenlight Guru’s Quality Event Automation eliminates the inefficiency associated with quality event processes by automating the necessary steps for a quality event and removing excess documentation. This new functionality delivers automated workflow templates built by users to incorporate specific, detailed steps following their company’s protocol. These automated workflows can be further tailored to the needs of individual quality event types.
David DeRam, CEO of Greenlight Guru, said: “In such a fast-moving industry, we are forced to balance speed and quality. Historically, when it comes to handling quality events, quality professionals rely heavily on the processes defined in work instructions, various forms, flow diagrams, and other disconnected documents to better understand their next step. This exposes a company to unnecessary risk and potential for error in information being documented incorrectly or not at all. Greenlight Guru Quality Event Automation introduces an optimised approach to managing the entire quality process that drives improved outcomes and allows teams to streamline new or existing processes while operating within a framework aligned to industry standards and best practices.”