Let’s see how you can manage your QMS documents in Formwork. First off, what’s the difference between documents and records? In short, documents are versioned, i.e. old versions of documents are kept around, and documents can only be approved by someone reviewing it and “signing off on it”. Records, on the other hand, don’t have versioning and don’t necessarily need approval. Here’s a handy table:
| Documents | Records | |
| Versioning | Yes, old versions are stored in Formwork. Any time you edit the document and send it out for review, a new version is created. | No, editing a record overwrites the current contents of the record. |
| Approval | Must be approved through review (but self-review is possible if you toggle this setting in Formwork). | Can optionally be approved through review. Can also be self-approved without review. |
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.
If you’d like to learn about records, click here. If you’d like to learn about documents, this is what this article is all about, so read on!
Alright. Now, when you click on “Documents” in the left menu of the QMS section, you’re greeted with something like this:
Anyway, you can already see the first benefit of Formwork: You can actually create folders. Believe it or not, many other eQMS software products out there don’t have this groundbreaking feature of.. drumroll.. folders.
Where was I. When you now want to create a new document by clicking on “+ New” above, you have two options:
- New Document: Just create a normal new document. It’s 99% likely you want to choose this. A normal document like this one has a title, rich-text content and can have file attachments.
- Upload File as Document: If you’re in the other 1%, you might want to create a “file-based” document. 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 document 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 document contents into Formwork and instead move whole files into the folder structure.
TLDR: Ignore this option unless you know what you’re doing.
We’ll focus on creating a normal new document now. Here’s how it looks when you click “New Document”:
Here’s what you can do:
- Type a title: Give your document a title, preferable a unique one. Example: SOP Document and Record Control.
- Content (big white space): Type out the content of the document. 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.
Cool! Once you’re done, hit “Save Document”. This saves your document as a draft. By the way, you can edit your document any time as long as it’s a draft, so feel free to hit Save even before your document is complete.
And another quick note: Formwork actually auto-saves your progress even if you don’t hit Save. This is very useful in case your computer spontaneously explodes or you throw it out of the window. I’ve heard some people do that because they get frustrated with medical device compliance!
Once you’ve created a draft document, here’s how it looks:
Click the three dots in its top right corner to see a fancy menu appear with actions you can perform on this document:
Here’s what you can do:
- Edit: Edit the document, duh.
- Release With Review: If you think this document is done and you’d like to release it, click here! You’ll select reviewers in the next step.
- Delete: Delete the document. This is only possible for draft documents – in all other cases, you have the option to Archive the document instead.
- Move: Move the document to another folder.
- Activity: View an activity / audit log on which actions were performed when on this document.
- Permalink: View the permalink to this document. This is super fancy. You might want to link to this document from other documents. But because this document might have newer versions in the future, you wouldn’t want to link to this specific old version forever, would you? The permalink always points to the newest released version, automatically. So use that. Very cool.
- Download PDF: Download this document 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 document, very cumbersome.
- PDF Settings: If you’ve created a particularly unwieldy document, 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.
Cool. Most of those should be self-explanatory. Moving forward, I’ll show you how the Release With Review action works!
Document Reviews In Formwork
Once you click on that, you see this review screen. Oh wait, no, first, a seemingly random authentication screen pops up (like a wild Pokemon)!
This is one of many things Formwork has to do to ensure FDA e-signature compliance. Among many things, you have to re-enter your credentials when performing actions related to signing documents. Think this is useless? Yes, sit down on this couch and let’s discuss it.
Well, maybe another time, because we have more urgent matters to attend to – sending out a document for review!
The review screen allows you to select who should review your document. In Formwork, this is a bit different than in other eQMS software, because you select the role of the person who should review it. As you can see above, I selected the CEO to review it and I added a note that the dude should take a look and review.
Now, who the hell is the CEO? That depends on how you set up your Reviewer Roles in the left menu. More on that in this separate article on Reviewer Roles.
Hit “Send For Review” and the document is off for review! Here’s what happens next:
- The document can no longer be edited.
- The reviewers are notified via email, and the review pops up on their “my activity” screen.
- When all reviewers have approved the document, the document automatically gets released.
- You can cancel the review while it’s in progress and revert the document to a draft.
Once a document is released, you can no longer edit it. But you can create a new version of it which itself is a draft, by clicking on the three dots in the top right corner.
And that’s it – you’ve released your first document in Formwork!
