Question
We are a startup and are in the early stages of getting our medical device FDA approved. We are currently looking at eQMS software to manage our QMS process. We have to adhere to the “FDA 21 CFR Part 820” Quality System Regulation (QSR). We are considering Formwork but are also looking at other systems.
We are still new to the process and really like what you are offering. Could you please help us understand how / if Formwork is suitable to address what 21 CFR Part 820 is requiring? Some of your competitors claim to be “compliant” with that regulation but we don’t know what “compliant” actually means in that case. Is it just the set of features that are offered? Or an official certification that the QMS supports it?
Would you be able to help us figure out of Formwork would be suitable to fulfill this? We’d love to make your tool work for us.
Short Answer
There’s no such thing as “21 CFR Part 820” compliance or certification. Only the content matters - i.e., the documents you create. You could create those documents in Formwork, Google Drive or even on paper!
Formwork would be suitable for your purposes, but any other document editing and management tool like Google Drive would, too.
The eQMS industry is shady and salespeople tend to over-promise and over-complicate things. Don’t trust them. Get free trials of each eQMS software (we offer one!) and compare them for yourself.
Long Answer
First off: Thanks so much for giving Formwork a chance, I really appreciate it! The marketing strategy of our competitors tends to be “claim crazy compliance and make everything sound very complicated” while we prefer to stick to the facts. That often puts us at an disadvantage because we don’t over-promise. So again, thanks for giving Formwork a chance!
There is no such thing as “FDA 21 CFR Part 820” compliant software. What that regulation does is this: It describes the contents of your quality management system. So you could create a compliant quality management system by simply typing out all your documents which cover those contents in a simple tool like Google Drive, or even on paper in your office! There will be some minor things you’d have to look out for, e.g. to have a “compliant” tool for electronic signatures, but besides that, it really only matters which content you create in whatever document editing tool you use.
And talking about electronic signatures, there are a few hard requirements of eQMS software tools which make them more suitable for creating this sort of documentation:
- Electronic signatures - the FDA has some requirements for those, e.g. you should re-enter your username and password upon signing.
- Versioning of documents - you should keep old versions of documents around (not that hard to implement, but sometimes tricky in GDrive).
.. and that’s it, more or less. If eQMS software vendors now claim their software is “FDA compliant”, that’s essentially what they mean. It’s an overblown term. A bit like claiming that a screwdriver is “spaceship compliant” if an astronaut takes it to space. I mean yes, it kind of is, but in the end it’s just a tool like any other and it has enough features so that you can take it to space - which might be no additional features compared to “earth-bound” screwdrivers at all!
Now, the typical way to prove that an eQMS software fulfils any sort of requirements is by filling out a so-called “validation form” (link to our free template) where you enter which requirements the regulation has and how the software fulfils it. We provide the filled-out version of this form to all paying Formwork customers. Not sure if we have one for the FDA though, I’d have to check with my colleague who does this in our company. If we don’t have it (we only have a few FDA customers), we’d happily create it for you and fully support you to make Formwork work for your FDA submission.