New capability automates the quality event process through customized templates that increase efficiency, reduce missed steps and maintain consistency for each quality process.
INDIANAPOLIS — October 19, 2020 — Greenlight Guru, the leading medical device quality management software (MDQMS) platform, today announced the launch of 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.
Today, medical device quality managers handle quality events by following defined processes and using various forms, flow diagrams and other documents. This cumbersome manual process not only increases the likelihood of missing important steps in the quality event process but also forces 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, helping teams maintain consistency in their work through a single, up-to-date workflow template with management controls in place.
“In such a fast-moving industry, we are forced to balance speed and quality,” said David DeRam, CEO of Greenlight Guru. “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 optimized 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.”
Other features available through Quality Event Automation include:
- Creating automated tasks within Greenlight Guru that assign the correct action items to the right user or group
- Developing multiple templates tailored to the specific needs of different criticality in your processes
- Ensuring your team works from the most up-to-date process template with documented activity history of each template
This launch follows Greenlight Guru’s introduction of Visualize, machine learning-powered capabilities that redefine how medical device manufacturers approach closed-loop traceability — yet another step in helping medical device companies move beyond baseline compliance and achieve True Quality. Greenlight Guru Quality Event Automation is available as part of their postmarket workflows, allowing event managers to create company-specific, customized and automated quality event workflows within the guardrails of Greenlight Guru.
To get your free demo of Greenlight Guru Quality Event Automation, please visit https://www.greenlight.guru/quality-event-automation.
About Greenlight Guru
Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices.