Formwork eQMS Manual September 17, 2024 · 2 mins read · Last updated October 28, 2024

The Formwork Manual

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: DocumentsRecords | 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 inputsSoftware 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


Dr. Oliver Eidel

Dr. Oliver Eidel

I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.

Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you’re still lost and have further questions, reach out any time!
More about me

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