Greenlight Guru Modernizes Validation Approach to Streamline Software Implementation and Adoption for Medical Device Companies

The risk-based approach to software validation will help customers efficiently and effectively assure compliance when implementing Greenlight Guru software.

Greenlight Guru, the leading provider of cloud-based software for MedTech companies, today announced that it is adopting an automated, risk-based approach to software validation and strategically updating its Software Validation Package for customers. The modernized approach is in line with FDA guidance on Computer Software Assurance (CSA) and requirements of ISO 13485:2016 to ease the burden of validating new software for MedTech companies.

In the 2023 MedTech Industry Benchmark Report, one of the top challenges cited for managing quality was the cost and effort of validating new software tools and processes. This is mainly due to the more cumbersome approach to software validation—known as computer system validation (CSV)—that has traditionally been used in MedTech to meet regulatory requirements.

In 2022, FDA released a draft guidance, Computer Software Assurance for Production and Quality System Software, as part of a greater, industry-wide shift toward a more balanced approach to software validation for MedTech companies. This new approach will make it easier for MedTech companies to adopt new technology and explore the full potential of software tools for their businesses.

“The shift from CSV to CSA is a move toward a more balanced, risk-based approach to software validation,” says Brian Gaffney, CTO of Greenlight Guru. “We’re excited to be modernizing our validation approach at Greenlight Guru because it will allow us to release software faster and improve the pace of innovation without jeopardizing compliance for our customers. It also streamlines the implementation of our QMS solution for customers, which is a win for everyone.”

In light of the shift to CSA, Greenlight Guru’s Validation Package has been strategically updated to align with the best practices and requirements in the FDA’s guidance on Computer Software Assurance and ISO/TR 80002-2:2017, Validation of software for medical device quality systems. The Validation Package will enable teams to efficiently and effectively implement and adopt the latest software enhancements and functionality while assuring compliance with evolving validation requirements. 

“Modernizing our validation processes helps ensure we’re doing everything possible to help our customers easily implement Greenlight Guru and get their life-changing medical devices to the patients who need them most,” says David DeRam, CEO of Greenlight Guru. “Ultimately, this shift is about helping MedTech companies keep up with evolving industry requirements and focus their resources where they matter most.”

When asked about the benefits of the updated Software Validation Package, Greenlight Guru customer Mary Head, ISO 13485:2016 Lead Auditor and Document Control Team Lead at DNAe, shared the following: 

"The vast majority of software platforms are not built for medical device companies and therefore require painstakingly hard and time-consuming validation processes. With Greenlight Guru, we do not have to do any of that. We are excited about this shift in the industry and it is such a value-add to partner with innovative companies like Greenlight Guru who are at the forefront of this evolution and making software validation even easier for medical device companies."

This announcement of an updated software validation approach comes on the heels of Greenlight Guru’s recent launch of Risk Solutions, a first-of-its-kind complete risk management solution that leverages AI-generated insights with intuitive workflows aligned with ISO 14971:2019.

To learn more about Greenlight Guru’s approach to software validation, visit https://www.greenlight.guru/medical-device-software-validation.