Greenlight Guru Modernizes Validation Approach to Streamline Software Implementa… – Press Release


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

INDIANAPOLIS, June 1, 2023 /PRNewswire-PRWeb/ — 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In 2022, FDA released a draft guidance, Computer Software Assurance for Production and Quality System Software, as part of a greater, industry-wide shift toward a more balanced approach to software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…