Creating QMS Records in Formwork

Let’s take a look how you create QMS records in Formwork. As a quick reminder, your QMS in Formwork has two types of “things”: Documents and records.

In contrast to documents, records are rather simple: They don’t have a version history, and they don’t need to be reviewed by another person for approval. You’ll see how that works below.

So the TLDR is that Records are less fancy. This article is about Records. If you’d like to learn about Documents instead, click here. Here’s a quick comparison table:

Those are the technical differences between documents and records. Now the question is when to use which? For that, check out this other post on documents vs. records.

Here’s another fun fact about records: The term “record” actually includes more stuff than simply the rich-text records you’ll be creating in this article. A “record” in a QMS can nearly consist of anything related to your QMS or product which you save somewhere. So e.g. the Techdoc items you save in Formwork (that’s another section of Formwork) are records, too! And if you’re using a tool for customer support, the entries there might be records, too. You get the idea.

So let’s get started. In the QMS section of Formwork, click on “Records” in the left menu. You’ll be greeted by something like this:

If you’ve read the article on creating QMS documents in Formwork, this is very similar. And yes, records can also have folders in Formwork, that’s something which surprisingly most of our competitors don’t have (it’s a crazy industry).

Anyway! In the top right corner, you can create a new folder by clicking on “+ New Folder”. You can also create a new record by clicking “+ New”. Let’s do that.

Just like with documents, you get two options:

• New Record: Just create a normal new record. It’s 99% likely you want to choose this. A normal record like this one has a title, rich-text content and can have file attachments.
• Upload File as Record: If you’re in the other 1%, you might want to create a “file-based” record. The most common use case is to upload a Microsoft Word (ugh) file here. It will also mean that Formwork will not show you its rich text editor, because it assumes that the content of your record is in the file you just provided. People use this feature when migrating their existing QMS to Formwork, specifically when they don’t want to copy-paste record contents into Formwork and instead move whole files into the folder structure.
  TLDR: Ignore this option unless you know what you’re doing.

Let’s create a normal record now. Here’s how it looks:

Yeah, it looks exactly like creating a new document. Here’s what you can do:

• Type a title: Give your record a title, preferable a unique one. Example: Job description of software developers
• Content (big white space): Type out the content of the record. I’ll trust you to know how rich-text editors work. A few cool things about Formwork: You can create tables (cool!) and you can insert image attachments.
  Another cool thing: Documents and records are actually saved in Markdown format internally. This means that, if you’re a technical person, you can also copy-paste existing Markdown files into Formwork, e.g. your documentation from GitHub / GitLab. To toggle the Markdown view, click on “Markdown” in the bottom right corner.
• Click to Attach Files: Optionally, attach one or multiple files here. Typical use cases for this are Word Documents (ugh) or PDFs from your old QMS (if you had one), or flowcharts (ugh). In most cases, you don’t need this.

And a quick note here: As you see in the Formwork hint in the screenshot above, only use this for QMS records, i.e. records which concern your entire company (e.g. CAPAs, HR stuff, etc.). Don’t use this for product-specific records! That’s because Formwork has a fancy other way of creating product-specific records in the Techdoc section. I’ll write that up and link to it here once it’s done.

Moving forward.. once your record is done hit “Save Record” to save it. Let’s see what you can do next!

Here’s a record from our own QMS. It’s a CAPA. As a quick note, Formwork actually has a feature for CAPAs, so you shouldn’t write out “rich text” CAPAs like we did here (we created this one before we had the CAPA feature, back in the stone age).

Here’s what you can do:

• Edit: Edit the record, duh.
• Release Yourself: This is specific to records! Records have less strict release procedures, so you can release a record by yourself without involving another person as reviewer.
• Release With Review: If you think this record is more important and needs to be reviewed by at least one other person before release, click here! You’ll select reviewers in the next step.
• Delete: Delete the record. This is only possible for draft records – in all other cases, you have the option to Archive the record instead.
• Move: Move the record to another folder.
• Duplicate: Duplicate the record.
• Activity: View an activity / audit log on which actions were performed when on this record.
• Permalink: View the permalink to this record. Use this when you link to this record from within other records.
• Download PDF: Download this record as a PDF, e.g. when you want to hand it in to auditors. In most cases, you’d want to use the Batch Export (left menu) for this instead as otherwise you have to manually download every record, very cumbersome.
• PDF Settings: If you’ve created a particularly unwieldy record, e.g. by adding a table with a million columns, you can change the PDF export settings here. The most common way to solve this is to set the PDF export to A3 instead of A4, and set the orientation to landscape. You’ll figure it out. This is better than Atlassian Confluence, by the way, which just creates crappy PDFs no matter what you do.

In summary, this is almost the same set of features like for documents. The notable exception here is Release Yourself – only records have that. Documents always need a review for release, records do not.

If you’re interested in how the review feature works, check out the document article here in which it’s described. And if you’re interested in how the “release yourself” workflow works, read on!

Releasing Records Yourself In Formwork

When you hit “Release Yourself”, you have to re-enter your email and password for FDA compliance reasons (yep):

Next, you’re greeted with this release screen:

It’s, umm.. pretty self-explanatory. You can optionally add a comment to your release and then hit the big blue “Release” button. Done!

Editing (Amending) Released Records in Formwork

Once a record is released, it can no longer be edited. That was the whole point of releasing it, right? But you might find yourself in the tricky situation that you really want to make edits to a released record. No worries, Formwork has you covered!

Again, the regulation of document control for records is less strict than for documents. So you can amend a record. Here’s how it works:

When you view a released record and click the three dots in the top right corner, the menu gives you the option to “Edit (amend)” a record:

When you click it, here’s how it looks:

With the rich text editor available again, you’re now free to make any edits to the record! However, you should describe what you amended and why in the yellow box above. This will be appended to the Release section at the bottom of the record.

And that’s it! That’s all you need to know about records in Formwork 🙂