Documents and records are the most important concept for your quality management system. In Formwork, you interact with them most of the time in the QMS section of Formwork which you can navigate to by clicking on QMS in the top menu.
In simple terms, the QMS section of Formwork maps to the requirements of the ISO 13485, which is the standard for quality management systems in medical devices.
Here's how the QMS section looks in Formwork:
Formwork QMS Section Overview
In the menu on the left side, you have access to other QMS sections, e.g. documents and records, which this part of the manual is about.
Documents and Records are about Rich Text
What are documents and records? In simple terms, both are what we would colloquially call documents - like a Google Doc, which you would create in Google Drive. It has a title and it has content, where the content again is rich text content with headings, tables, and images.
Now, in the regulated medical device compliance world, documents and records have a few differences which end up being quite important:
Documents are "stricter": You can only release them with a review, so someone has to electronically sign off on them; and there's a version history, so all prior versions of a document are stored.
Records are "less strict": You can release them without a review, and there's no version history. So changing a record usually means you change the content in place and the prior version of the record is not stored.
So far, so good. But as always, to make things more complicated, those two statements included a few simplifications and there are a lot of small details which matter too. Among other things, a record can optionally also be released with a review and in some cases we actually do store the prior version history of records. But we'll get into that in a bit.
Let's look at documents first. For that, click on Documents in the left menu in Formwork:
Formwork Documents
You will be greeted by this screen:
Formwork Documents
(As you can see, we've reached our document limit with the AI generation in this free account but let's just disregard that for now)
Folders
Formwork documents are organized in a folder structure, very similar to your macOS Finder, Windows Explorer, Dropbox or Google Drive. You can create folders, you can create documents and you can drag and drop things to move them around:
To create a new folder, hit the New Folder button in the top right corner.
And to move a into a folder document, simply drag it there. You can drag and drop documents into the big-text folders you're seeing in the center, but you can also drag them to the folders in the left menu.
The left menu simply shows a smaller view of your folder collection.
