Ah yes, the age-old question. When to create something as a document vs. when to create a record? When I started working as a regulatory consultant back in 2020, I thought this question would be settled when I had acquired more knowledge, but it turns out that it's one of those Heisenberg-style things where everyone has come up with their own answer, and there doesn't seem to be one objective answer to it (sad dog face).
The #1 article on this topic has been written by my colleague Sören, check it out here: Documents vs. Records.
I could launch into an academic discussion on their differences, but I'll just give you some examples of documents and records:
The #1 article on this topic has been written by my colleague Sören, check it out here: Documents vs. Records.
I could launch into an academic discussion on their differences, but I'll just give you some examples of documents and records:
Documents
Examples
- All SOPs (= document processes of your quality management system)
- All Templates (= document templates your company is using)
Notable features
- A document is always versioned! Any time you send it for review, Formwork creates a new version, starting with v1 (then v2, v3, etc.).
- A document (or rather, its version) can only be released through a review (though self-review is possible - you can configure this in your Formwork settings).
- If a review is rejected, the rejected document is either kept around or is deleted (also configurable in your Formwork settings).
Records
Examples
- Everything else!
- Plans, which are usually outputs as mentioned in one of your SOPs
- Reports, which are usually also outputs of your SOPs
- Work Instructions
- "Tables": e.g.:
- A list of the software you're using in your QMS (as part of your QMS software validation)
- A list of your suppliers
- "Filled out forms", e.g.:
- Filled out software validation form for each software you're using in your QMS
- Filled out supplier evaluation form for each of your supplier.
Notable features
- Records can exist either in your QMS (QMS section -> Records) or as part of one of your products in Formwork (Products -> (select product) -> Records).
- A QMS record doesn't have any version history - in contrast to documents, editing a record "overwrites" the current record.
- A product record ´actually does have a version history, it is versioned as part of the product version it belongs to, e.g. "My Medical Device v0.0.1".
- Records can be released immediately, if you like; but you can also opt to release them with a review, just like documents (yes, stuff gets even more confusing).
Yeah, it's a bit complicated.. you will figure it out :)