The only eQMS specifically for medical device will enable companies to move beyond baseline compliance to True Quality.
INDIANAPOLIS -- Oct. 30, 2017 -- Greenlight Guru announces the addition of Grow to its existing quality management software platform, helps companies get high quality medical devices to market faster and with less risk. Now, with the introduction of their Grow product, Greenlight Guru’s software can assist medical device companies after the launch of a device by connecting its entire quality ecosystem and advancing the success of high-quality devices already on the market.
According to the FDA, Corrective and Preventive Actions (CAPA) continue to be the number one reason medical device companies are cited for 483 Observations. The reason is because many medical device companies are still using a paper-based system to connect the disparate processes, sources, people and data within a quality system. Or, the companies are opting for an eQMS that isn’t tailored toward the medical device industry and doesn’t address the changing FDA regulations and ISO standards in which the medical device industry must adhere.
“After experiencing this pain firsthand working in product development and management for medical device companies, I knew there needed to be an easier way to help companies not only get to market faster but improve their post-market quality processes beyond just compliance,” said Jon Speer, founder and VP of QA/RA at Greenlight Guru. “Grow has additional workflows for CAPA and other post-market needs that will help these companies who are flying blind without visibility into their quality system and are subject to unnecessary risk."
With Go, Greenlight Guru’s first product, companies utilize design control, risk management and document management software to bring FDA and ISO-compliant medical devices to market in less time. Now with Grow, companies will have the necessary visibility into all their quality processes to achieve True Quality by applying:
- CAPA Management. Find the root cause of CAPAs sooner and produce output reports on demand to verify resolutions.
- Customer Feedback Management. Streamline customer feedback and complaint processes that aligns with FDA regulations.
- Nonconformance Management. Reduce non-conformance cycle times and the risks associated with your device.
- Audit Management. Conduct internal and external audits, automatically route findings based on risk, and easily share results with a single click.
- Change Management. Understand and manage the impact of any change.
- Training Management. Ensure the right people receive training on the right things.
"The new Greenlight Guru Grow product will be very helpful in our ability to escalate and manage quality events that require a CAPA investigation,” said Eric Rock, customer and QA/RA Manager, Litecure. “Being able to easily link and connect nonconformances, complaints, audit findings, CAPAs and documents will greatly improve our internal efficiency and compliance and allow us to put our focus squarely on the quality of our products."
"Grow is a disruptor for the medical device industry," said David DeRam, co-founder and CEO at Greenlight Guru. "Companies can now use quality as an accelerator, confidently connecting all the pieces of their quality system to get the visibility they've been missing, leading to higher quality devices, better business and ultimately, better lives.”
To learn how to implement and maintain a modern CAPA system while avoiding the common pitfalls, register for Greenlight Guru’s upcoming educational webinar with FDA News on November 8, 2017.
For more information or to get a demonstration of the new Grow product please visit www.greenlight.guru.
View the full press release here.