Copying records is tedious. What do I mean by that?
The documentation of your medical device software contains many records. Examples for records are your software requirements list, your software test plan, and most importantly, your declaration of conformity. And probably 99 more. Lots of records.
Now, when you release a new version of your medical device software, what the hell do you do with those records? Some of those need to be updated because stuff changed (like maybe your software tests), and all of your records have to be copied, because your auditors will expect you to have a complete set of documentation for each version of your medical device.
So this ends up being a whole lot of busywork – one poor person in your company (typically the regulatory dude / dudess) has to copy-paste all records from one folder to another, make some changes to some, and re-release all. Ugh.
Today, we’ve shipped a feature to Formwork which solves this.
Any time you create a new product release, all of your records are automatically copied. Here’s how the list of records looks then:
The small symbol next to the version (the squiggly line thing) shows you that this record is linked to other copies in other product versions. After opening a record, you can view those other versions:
So – no need to copy-paste records. It’s all done for you, and Formwork links the records to their prior version.
All you need to do is to check all records whether their content is still complete and current, and re-release them. All done!
What’s the efficiency gain here? For mid-size to large software medical devices, this could easily save you multiple hours, or even a one-digit number of days. And then there are second-order benefits, too: Now that all your records are linked to their older counterparts, you don’t lose time hunting around for old records (like when your auditor asks you “what were your software tests for version 0.0.2?”).
Copying records is part of the Techdoc feature, which itself is a Formwork Pro feature for. But, as always, all the basic QMS functionality in Formwork is free in its Community Edition. That includes creating documents and records in a compliant way. Check it out 🙂
