The Formwork Manual

Dr. Oliver Eidel
Updated October 28, 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 need any help with your EU MDR efforts?
We’ve worked with 100+ companies and helped them certify their devices in weeks, not months. Talk to us now – first calls are free! Check out our services and prices here.

Or, if you don’t like talking to humans, check out our Wizard instead. It’s a foolproof, step-by-step video course for getting your compliance done yourself.

And if you’re looking for the best QMS software for lean, founder-led companies, check out Formwork. It automates your compliance, and there’s even a free version for you to try out!

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