Greenlight Guru Reviews

Greenlight Guru's workspaces are well thought out and comprehensive.

As Greenlight Guru is so comprehensive there is a lot of training needed to prepare new users despite it being easy to use.

Greenlight Guru was chossen to make efficencies in how our company develop new products.

The functions in GG are so simple to use. It makes regulatory compliance a breeze.

I truly have not found a thing that I dislike about GG.

GG is managing not only our Customer Feedback (Complaints), but also our Document Change Control. The fact that Greenlight provides their customers a Validated system for their complaince documents is a huge bonus. GG also will send you updates to their validation document as newly developed upgrades to their software occurs. Bravo GG!!

The ease of use and on going support from consultants

Password resets. If you dont log in for a while, you get deactivated.

Storage of documents and capa/audit automations

It is easy to use and logical. The platform is also 21 CFR 11 compliant and majoritily validated by GreenLight.

There is no complaint module. I am forced to use the Customer Feedback module for complaints :/

Good documentation practices.

Greenlight Guru is built specifically for medical device manufacturers and was built to comply with the applicable regulations for meddev.

Greenlight Guru did not have an open API at the time of our implementation, but this is something they are working on.

Greenlight Guru has provided us with an eQMS that will house all of our quality systems into one system all within a system that complies with FDA regulations. Greenlight Guru offers a user friendly, intuitive eQMS providing internal customer statisfaction in addition to regulatory compliance.

Greenlgiht Guru has been implemented as our eQMS and has made document managment, review and approval very efficient. The software is user friendly and most of our staff are able to use it intuitively. Greenlight Guru are very focused on making improvements and they have taken on much of our feedback and acted on it. In my opinion, the best features are the ability to link anything (documents, training, Audits, CAPA, NCs) to one another. flexible document management with customisable values and attributes, and the overall UI. Greenlight Guru has really made Audits a much smoother process.

Areas for improvement for greenlight would be management of tasks, document review cycles, and more flexibility for the in the Change workspace i.e. reviewers not needing to review every document and evaluation in a CO. Greenlight Guru have been proactive in seeking feedback and they have been great at providing updates on the impvorements they are working on.

Greenlight has removed the need for almost all our paper based documents and records management. We use it to issue and record all of our training across the company

Upsides include:

- GG Customer Service, Account Management, and Product Designers are consistent, solicit VOC, and are responsive

- all required QMS procedures in a single software platform

- relatively easy to implement

- user acceptance

- continued support from GG

Items to work on:

- please, please, please come up with a training matrix

- add ways to help prove training competencies (e.g. quiz's)

- help make it easer to get quality events into the system

- adjust the viewing permissions of lite users

Everyone (in-office and remote) can access required documents, and user acceptance seems high so far, which I hope leads to compliance. The simple interface is modern and easy-to-use, yet meets the requirements in a robust manner. This is the first time I won't be nervous heading into an audit.

The quality of the software, its user friendliness, the knowledge of the Gurus with regards to the software and regulatory requirements, the onboarding programs

I can't think of any downside of anything I dislike about it

I think this is fabulous software. The Gurus are extremely knowledgeable about both the software and the medical device industry regulatory requirements and the software. The have an excellent onboarding program and the software is very user friendly. It provides the templates for all of the procedures a company require to meet 21CFR 820. ISO 13485/2016 and MDR 2017. It would be an enormous and costly task requiring a lot of resources for small start like us to understand the regulations well enough to create all the documents and procedures to meet to meet these regulatory task.

It helps and support the company to do the right thing in relation to standards and regulations.

Some functions for example searching for documents are not very user friendly.

Electronic signatures, document review and approval, version handling, templates for SOPs and WIs. We have quickly succeded to obtain ISO 13485 certification. The NB was very impressed with GG and the way we used it for our QMS.

Puts the major components of QMS into one software location that makes it easier to locate documents and actions taken within the CAPA and Audit functions.

The software needs more automation built in such as when you deactivate an employee, the software should automatically remove the deactivated employee from the training modules that are in progress. Overall though this remains a solid software system and GG is making upgrades continually to improve the software based on customer suggestions and recommendations.

Revisions and changes to procedures are easily captured within GG which solves the issues of errors and manual input into a revision history. Procedures as well as training assignments are available with a single login to all employees.