Traceability Matrix: GreenlightGuru vs. qmsWrapper

If you work in a Medical Device company and you are preparing your product to get on Market, first, you’ll need to get FDA approval (US Market) or CE mark (European Market).

Before that, you need to prepare a lot of documentation, so the terms that will scare you the most are Design History File — DHF (US) and Technical File — TF (EU).

A-Design History File is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act. It was established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. –Wikipedia

A Technical File is a set of documents that describes a product and can prove the product was designed and according to the requirements of a quality management system.

All products that have a CE mark must have a technical file which must contain the information that proves the product conforms with the EU directives for CE-marked products.- Wikipedia

I know… many requirements, tasks, meetings, decisions that you need to record. It is a real nightmare!

But, Traceability Matrix (TM) is created to map out and organize these issues from the start to the end. I like saying that TM is a dashboard — some kind of table where you can follow your projects. When the auditor comes, there is no more stress with a convenient tool.

Discussing with my colleague, we agree, that there are many solutions for TM. If you select the wrong one, the solution won’t help you solve the problem.

Because of that, we decided to compare two software that we know the best: GreenlightGuru and qmsWrapper.

qmsWrapper’s Traceability Matrix:

  • clear overview of medical device life-cycle
  • flexible structure
  • not only for DHF/TF purpose
  • multi-user function
  • integrated with Jira software

GreenlightGuru’s Traceability Matrix:

  • changes are easy to follow
  • the only purpose is DHF/TF
  • predefined columns (related to Design and Development)
  • more columns can be added on the written request

Three more differences that can be important when choosing the right solution can be:

Team chat

GreenlightGuru doesn’t have integrated Team Chat. Users only can add comments on certain files.

qmsWrapper contains a Team Messaging module. Users can have chat: 1-on-1, group/topic-based/threads conversations,… Discussion can be added to any project or task and save as a meeting. Many options are available.

How is the work organized?

qmsWrapper is Project-based software, so the work is organized per project? That gives more flexibility to the Users because you can use the software not just for QMS related events. GreenlightGuru is Module-based, like the most of QMS software. Work is organized per separate modules (CAPAs, non-conformance, etc.).

Document Management

GreenlightGuru’s Document Management is a list of files, it is a little bit confusing because it is unorganized well (it is hard to understand its origin). qmsWrapper’s DM (storage) is much better organized-per projects (the user is always aware which document is a part of what exact project).

Both software, GreenlightGuru and qmsWrapper, have both positive and negative sides.

If you have already used some module-based software, I would recommend GreenlightGuru because you are already familiar with this system. Reserve Live Demo and discuss with their support team about your company’s needs.

If you are new to the QMS world or switching from paper-based to eQMS, my warm recommendation is qmsWrapper. Reserve Live Demo and find out more about qmsWrapper’s features.

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Charles

Charles

5 years medical regulatory consultant, before I was food inspector. Writing become my passion. Member of qmsWrappers author team.