Greenlight Guru

We needed an eQMS system.

We use Greenlight Guru to address company-wide training initiated by our Quality department. It's a great repository and electronic document management system for quality system and non-quality system documents. This system ensures everyone is up to date on their training and is trained to perform their daily tasks. It also keeps a record of everyone's training in case the company is audited.

Greenlight Guru is our company's go-to for an eQMS. Using Greenlight Guru has made our processes much more efficient and allowed us to do away with signing off on and managing physical paperwork. Because of Greenlight Guru, our focus is more on quality rather than compliance, because Greenlight Guru makes the compliance stuff easy!

Greenlight Guru is used at our organization as our Quality Management System. We utilize it to be compliant with ISO 13485 and FDA 21 CFR. We specifically purchased Greenlight Guru because it has a unique and innovative Design Control Module and Risk Management Module. As opposed to using a controlled Excel sheet, the design control module is thought out, compliant, and easy to generate the DHF.

We use Greenlight Guru for all of our Quality Management System needs, including design controls, document control, and risk management. Greenlight Guru allows us to develop our medical device products in a way that is compliant with requirements from the FDA and other regulatory bodies and is easily auditable for both internal and external audits.

Greenlight Guru houses our electronic quality management system, which is essential for compliance in a highly regulated industry like medical devices. Nearly the entire organization has to use it, and it helps us streamline quality management, risk management, and design controls.

We use Greenlight Guru across our organization and it replaced an outdated "clunky" document management system. Greenlight has significantly improved our productivity and quality management system.

It is used across the whole organization. We now have a system where everyone can feel comfortable [using] and controlling the company documents.

Greenlight Guru is being used to house our entire Quality Management System, and serves as our document control and records system. The change-order process for all QMS documents is also controlled through Greenlight Guru. We are also using it to create, track, and address CAPAs and complaints, non-conforming product, internal audits, and training.

We are also starting to use the product development and risk management modules for new product development. The built-in traceability matrix for design controls has taken some changes to our existing development process to implement, but as we get through the learning curve, we are really starting to see the potential.

We utilize Greenlight Guru for document management across our entire company. The product addresses our need for a paperless system that ensures compliance with the necessary regulations and standards.

Greenlight Guru is a solution for the following: Document Management, Change Orders, DHF Creation, Traceability, Post market including customer feedback, audits, CAPAs, non-conformances. It is our source of truth for everything related to full lifecycle development of our products from concept to post-commercialization, complying to the applicable 21 CFR Part 11.

Greenlight Guru is used across the whole organisation. It addresses all aspects of QMS per ISO 13485:2016, ISO 14971:2019 and FDA QSR.

Greenlight Guru is being used to manage projects of the company and store information and document such as SOPs, FDA communications, and other documents. We use it as an audit (internal and external) and customer feedback platform. Changes to SOPs and other documents are managed through GG. QMS training is also managed through Greenlight Guru.

Greenlight Guru was implemented as an electronic quality system to replace the paper-based system at our company. It is being used primarily by the Regulatory/Quality and Product Development departments, but is also being used fairly regularly for the Operations and Marketing departments as well. The Finance department also has access as "lite" users so that they can access and sign off on relevant training. Greenlight Guru has helped greatly in the process to guide our quality system remediation efforts and helps to ensure that we are compliant with the US FDA Quality System Regulation. It also helps tremendously with keeping track of tasks, which helps to ensure that tasks are not left open for too long or indefinitely.

We use Greenlight Guru across our company to manage our Quality Management System. We design and manufacture class 1 and 2 medical devices. Greenlight Guru has been an essential tool for managing our various QMS requirements including design control, document control, risk management, employee training, etc.