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. Did you know that Formwork automatically creates this for you?

Formwork has had its "QMS Overview" feature for a while now, but recently we've made a lot of improvements to it. Check out the video below for a quick walkthrough:

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Purchase Formwork Starter From Within Formwork

If you're eligible for our Formwork Starter discount (49€ / month), you can now purchase directly from within Formwork.

The criteria are that you have neither funding nor revenue and your team consists of 3 people or less. If in doubt, ask yourself whether you're sitting in a garage and living off your savings. If so, we're happy to support you! We're not making a whole lot of money from Starter and it's our contribution to help Healthcare startups get off the ground.

Finally: Rejected Reviews Can Be Overwritten Now

Sometimes, early product decision come to haunt you. Case in point, I thought "hey cool, let's keep documents with rejected reviews around and archive them". Mostly a terrible idea, because there's no real point in archiving a document version after it has been rejected by review.

Finally, this changes - but only if you want it to change. Navigate to QMS Settings (top right corner) and turn off "Keep Rejected Reviews in Documents". After that, a document with a rejected review can be edited again, just like a sane QMS person would expect it to be.

Create Duplicates Of Records

You can now easily duplicate records! This was a much-requested feature. To be fair, it's a bit of a "be careful and don't shoot yourself in the foot" kind of feature. Because, mostly, you shouldn't be duplicating records.

There are some good (yet rare) use cases though, e.g. if you're creating software validation records for software you're using during development (GitHub etc.), as those often look quite similar. Big time-saver.

The Formwork Manual

In the past, Formwork didn't have a user manual. That's because it was very easy to use, and we also expected people like you to magically read our minds and know how to use it. The latter assumption proved to not be 100% true all the time, so we've started publishing the Formwork Manual. Check it out! It also explains some QMS and Techdoc concepts along the way, so it's fairly easy reading.

.. and lots of small improvements

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

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General

• Multiple-selection forms now have "select all" and "clear all" features.
• Subscribe in one step now (before, this was two steps as you'd have to cancel your trial).

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QMS

• CAPAs and Trainings now have icons for filtering and exporting their data.
• Documents / Records based on custom files (e.g. Word files) now have a larger file limit.
• Better handling of credit card subscription issues - you now get 30 days to resolve the issue while retaining full access to Formwork QMS + Techdoc. You'll also get an email notification from us.
• Archived users are removed from their respective roles.
• Fixed: OpenRegulatory template folder structure was jumbled up for a few hours.
• Fixed: Multiple minor issues regarding inline document comments.
• Fixed: Multiple minor issues regarding reviews.
• Fixed: Minor issue when linking to outdated documents.
• Fixed: In rare cases, table formatting broke when creating a new draft.
• Fixed: In rare cases, a change request with a rejected review couldn't be edited any more.
• Performance: The QMS overview page now loads faster for a large number of entries.

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Techdoc

• Failed test runs of your medical device are now shown in the sanity check. In other words, you probably shouldn't release your medical device if you still have test runs which have failed.
• Fixed: Minor issues with the audit export.

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As always, thanks for using Formwork!

If you're an early-stage startup (no revenue, no funding, 3 people or less), purchase Formwork with your Starter discount now (49€ / month) by navigating to Settings (top right corner) --> Billing.

For all other startups, we offer Formwork at a discount for 499€ / month instead of 799€ / month. Check out the Formwork page to learn more, schedule a call or simply reply to this email :)

Have a nice week ahead,
Oliver