What's New With OpenRegulatory Formwork? (January Edition)


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!


Customers Pass Audits With Formwork: Akina Health & Noah Labs

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.


Auditors Love This: One Big Techdoc Table

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!


Default Trainings For Roles!

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.


User Needs <--> Multiple Stakeholders

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!


Techdoc Record Diffs!

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!


CAPAs Can Have File Attachments Now

You can add file attachments to CAPAs now, e.g. if you want to attach proof of resolving the CAPA.


Custom File Documents Are Downloadable As PDF

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.


.. and lots of small improvements

As always, a gigantic ton of under-the-hood improvements :)

QMS

  • Visio (flowchart) files are now supported as custom file documents (those are documents which you upload as files and don't type in our text editor)
  • Require email and password re-entering when submitting reviews, too
  • Allow changing of company name

Techdoc

  • Requirements can be marked as "future"
  • Creating a new product release runs asynchronously now, less crashes
  • Automatically fill (and check) risk matrix probability categories
  • Prevent deletion of product if at least one released version exists
  • Self-start free trial of QMS + Techdoc even if you were lazy and didn't watch all videos of the Starter Course
  • Bug: Hide deleted systems and design inputs
  • Bug: Fix rare crashes when creating releases
  • Bug: Creation of Techdoc review sometimes failed

Wizard

  • Courses now include links to relevant templates and drafts

Other

  • More internal backups of (file) attachments
  • Improvements to chat support

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

OpenRegulatory

Read more from OpenRegulatory

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...