So you want to set up your Quality Management System (QMS) in Formwork. Alright!
When clicking on “QMS” in the top bar, you are greeted with this friendly “My Activity” screen:
The most important aspect of the Activity screen is that it shows you when someone sent you a document or record for review. It also shows you trainings you might have to complete. More on those exciting things later! Yes, that’s right, I’m sure you’re also excited about those things!
But first things first. On the left side, you see the QMS menu. Here are what those sections are about. Click on the link of each section below to learn more – if some things don’t have links yet, that means I’m working on them or procrastinating. Here they are:
- My Activity: We just talked about that. Duh.
- QMS Overview: Formwork helps you create a fancy overview table over all your QMS documents which you can show auditors. This will make them very happy.
- Consulting: You probably don’t see this in your account. This only appears in the very unlikely case that you’re a regulatory consultant and want to collaborate with your clients in Formwork.
- Documents: This is where your QMS documents are stored. Click on it to open up the folder structure.
- Records: This is where your QMS records are stored. Yep, click on it to open up the folder structure.
- OpenRegulatory Templates: A very awesome section. This is where you can access our completely free templates for your medical device compliance – they cover everything for your QMS and technical documentation for EU MDR medical devices! Same templates as on our website, but way more convenient because you can do easy copy-pasting.
- CAPAs: Manage your corrective and preventive actions (CAPAs). If you don’t know what that means, just skip ahead.
- Trainings: Manage your employee trainings. If you think that sounds dumb, then.. hm, don’t get into quality management.
- Reviewer Roles: Manage who reviews your documents and records in your team.
- Batch Exports: Export your entire QMS with just one click!
