Greenlight Guru

Greenlight Guru would make it easier to have fewer documents lying around, and everything is within one system.

The only less appropriate times is when you are looking for documents, it is not very intuitive and it takes a long time to do NCR's, complaints, and CAPA's because it does not let you just embed documents, instead you have to write every that you already have in the document.

Greenlight Guru is well suited for taking your quality management system from paper-based to an efficient electronic and validated system. It's convenient to manage users, documents, content, training, and everything required by external regulations, and put those to good use to remain organized, compliant, and quality-focused.

Greenlight Guru is a very revolutionary software that is the first software to my knowledge to revolutionize the creating of Design Matrices, Design History Files, and Risk Management. The other modules: Change Management, NCMR, CAPA, Training, etc have changed greatly over time and have improved tremendously. It could use some additional modules such as equipment management, supplier management, to make the software better. However, they are constantly adding improvements to the software, so I would imagine those modules will come within the next couple of fields. The software is not customizable at all. That does make implementation and adoption easy, but does limit functionality as many similar software have customization available.

Greenlight Guru is the perfect eQMS for smaller medical device companies, especially for users without extensive eQMS experience. I do not know if I would recommend it for larger enterprise customers. The most cost-conscious very early-stage medical device startups might be better off with a paper system, but I am very glad that we had the resources to start with Greenlight Guru from the beginning and did not have to make the switch.

Greenlight Guru is an excellent choice for companies searching for an electronic Quality Management System which complies to ISO 13485 and FDA regulations.

It is user friendly. The training management has saved my team hours of time not having to manage it.

Greenlight Guru seems ideal for small companies, and/or those in a start-up phase that need to start a QMS. We moved a mature QMS system for a small company from an old, legacy system to Greenlight, and it was relatively easy to do, but moving a large company QMS would be challenging. Moving old DHF and/or projects that are in process is challenging, and it is easier to start projects from scratch in the new software.

Greenlight Guru is an excellent eQMS for any medical device start up. The solution itself allows any quality/regulatory professional to educate their team on compliance to the applicable regulations just by using the solution. It has allowed me to delay hiring of additional resources. Greenlight Guru also provides excellent training resources for this start up organizations that are not available with other eQMS as well as industry experienced experts (Gurus) that have been in the industry and now work at Greenlight using their talents to help support their customers and ensure they are not only using the solution correctly but maintaining compliance while using it.

If you are working with a medical device and would like to go electronic, then Greenlight Guru is the way to go.

Greenlight Guru is well suited to make and track changes of documents as each document can be obsoleted and check out documents.