Formwork Documentation

Dr. Oliver Eidel
Updated October 1, 2024
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Everything you need to know about our eQMS software, Formwork.

Quite a few of articles below are still in progress – you’ll notice this if they aren’t clickable yet. Please bear with us while we fill in the blanks!

If you have absolutely no clue about eQMS software and Formwork, check out the Getting Started article 🙂 for all other topics, take a look below.

First Steps

Quality Management System (QMS)

  • Overview
  • Managing QMS items: Documents | Records | CAPAs | Trainings
  • Saving time: OpenRegulatory templates
  • Reviewing items: Reviewer roles
  • Very cool stuff: QMS overview
  • Finished and ready for your audit? Batch export

Technical Documentation (Techdoc)

  • Overview
  • Software / hardware documentation: Software requirements / design inputs | Software tests | Software test runs
  • Risk analysis: Risk matrix | Risk table | Failure modes | Hazards | Hazardous situations | Harms | Risk controls
  • Usability engineering: User tests | User test runs
  • Very cool stuff: Sanity check | AI drafting | Requirements overview | Risk overview
  • Finished and ready for your audit? Reviewing techdoc items | Audit export | Batch export
  • Product settings, versioning, changes: Product settings | Releases & versioning | Change requests

Courses

On a different note: Do you still have lots of questions about the EU MDR and would you like to talk to a human? No worries! Just book a free 30-minute consulting call.

Or, if you don’t like talking to humans, check out our Wizard instead. It’s a self-guided video course which helps you create your documentation all by yourself. No prior knowledge required.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to automate your compliance, look no further. We’ve built Formwork, and it even has a free version!

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