It's been a while as we skipped last months update, so we have two months of Formwork updates for you today. Our 10x developers (I'm serious) were busy at work and shipped one feature after another. Nowadays I look at our features and wonder whether other eQMS vendors have something similar - and, surprisingly, the answer often ends up being "nope". So, maybe, feature-wise, Formwork has surpassed its competitors? :)
Regardless of how far ahead we are, you are the one who benefits, because you can use all of the sweet new features to automate even more of your compliance work while your competitors are stuck with clunky eQMS software which doesn't do very much.
Enjoy!
Oliver from OpenRegulatory
PS: We're organizing a Healthcare Startup Meetup which is happening later today. It's online and free, sign up here!
I somehow never thought of including customer success stories here because I thought it'd be obvious that people companies pass their audits with Formwork, chuckle..
So here are belated congratulations to Akina Health and Noah Labs, both of which recently passed their QMS audits with Formwork :) you can read their testimonials on the Formwork page.
With Formwork, you can now display all your Techdoc requirements in one big table. Auditors love this! That's because it gives you a great overview and helps you double-check for whether any items are missing (e.g. do all your Design Inputs have System Tests?).
You can find it by navigating to Techdoc --> (left menu) --> Requirements Overview. And there's a Risk Overview, too!
You can now define default trainings for user roles - this is really cool because it saves you a lot of time as you no longer have to select applicable trainings for each user individually.
A Formwork customer requested it, so we built it! You can now link User Needs (formerly Stakeholder Requirements) to multiple Stakeholders. This is useful if you're e.g. building multiple, slightly-different software products for different countries, yet you want to keep one list of User Needs. In that case, you could solve that by having a Stakeholder named "English-Speaking User" and another Stakeholder named "German-Speaking User", and you'd like up the User Needs accordingly.
A bit of an edge case, but a relevant one!
In the last newsletter, we shipped the "document diff" feature which enables you to see the exact changes (additions / deletions) between your document versions. Now we've also implemented this feature for Techdoc records, as those are also versioned across your product versions (e.g. the Intended Use for v1.0 of your product might differ from the Intended Use for v1.1). Happy diffing!
You can add file attachments to CAPAs now, e.g. if you want to attach proof of resolving the CAPA.
In the past, we shipped the feature that you could create documents with your own text editor (e.g. Microsoft Word) and upload them to Formwork as, well, documents - instead of using our text editor.
One missing link here was that you could review and approve those documents as part of your Formwork approval workflow, but that review information would not be included when downloading them. This is now improved: When downloading them, you also get a PDF which includes the review information.
If none of this makes sense to you, just rest assured that your downloads and batch exports just got a bit better.
As always, a gigantic ton of under-the-hood improvements :)
QMS
Techdoc
Wizard
Other
As always, thanks for using Formwork!
if you're currently on the free plan and are considering upgrading, check out the Formwork page to learn more, schedule a call or simply reply to this email.
Have a nice week ahead!
Oliver
One of my colleagues recently postulated that Formwork "is the Lada of eQMS software" (Lada is a cheap car). He does have a point: Formwork is (much) cheaper than all eQMS software out there. But here's the thing: If Formwork were a Lada, happily cruising along on the highway, it would be able to fire up booster rockets and fly to the moon. Because nowadays, Formwork can do things which no other eQMS software can do. So, in that sense, I disagree with my colleague, because Ladas can't do...
Another double edition in which I hopelessly try to catch up with what our developers built in the last 1.5 months! Before we get started, here's something else which might interest you: Today, we launched a BEUDAMED, which is a better search engine for EU medical devices. Announcement, link to BEUDAMED. End of announcement. Let's look at what's going on with Formwork! Automation: QMS Overview Improvements Your notified body expects you to hand in a list of all your documents and processes....
Double edition this time! That's because we were in Barcelona recently to hang out and catch up (we all work remotely). In the meantime, it seems it was only I who was unproductive, as I didn't send out the newsletter last month. Our developers, on the other hand, shipped so many features that I have a hard time catching up now. Damn! Let's try! There's some really awesome stuff below :) Ah, and by the way, we're hosting a free Healthcare Startup Meetup online. It's happening next week...