Matteo Gubellini [SoftComply] Expert

... and if you throw in Jira with Assets, you can actually do a quite good combo including risk management, SoA and mapping to Annex A. Our Risk Manager Plus can do the job, we have a dedicated module for ISO 27001/27005, including automated SoA and Annex A linkage.

Hello, I doubt Atlassian have anything of the sort. Keep an eye on backups of comments and tracking of changes. Matteo

Done

Apologies, we are on it. Matteo

Hello, We have a free app with a macro that inserts the version creation date, which is what you are looking for I believe. https://marketplace.atlassian.com/apps/1229624/softcomply-toolbox-for-confluence?hosting=cloud&tab=overview Matteo

SoftComply Document Manager for stricter controls, depending on what standards you need to comply to. Ours focuses on MedTech industry and adjacent ones. Matteo

Interesting. I'm putting together our ISMS right now and I tried to create a Rovo bot to check my work. It turned out to be a people pleaser, even when I asked it to check the ISMS content against a Control that I had not implemented yet. Any suggestion?

Same here, did you find a solution?

+1

Hello, Two options: 1. Create a test instance, import the space and check the results 2. Edit the backup file and change the space key. I do it with XML exports, not sure how it works with CSVs. Then you can re-import it into the same instance. Matteo

Hello, You can find Apps on Confluence to have workflows and electronic signatures (we have our own SoftComply Document Manager) I am a ME myself and when I had to use Confluence (or any other document management system for what it matters), is was only used to upload prints e.g. PDF files) and sometimes 3D models (e.g.…

Hello Veronica, This seems to be a race condition issue between our App and Comala. If Comala loads first, then everything is fine, but if it takes longer than usual, the CHT macro won't find the required info. If you refresh the published page it should appear correctly. It could be also related…

Hello, We have released a fix for the App a few days ago, and as of today all export formats work correctly, including compatibility with Scroll PDF exporter. Matteo

Correct.

Hello @Veronica Rodriguez , We are going to release a fix in the next 1-2 days. Apologies for the inconvenience. Matteo

Hello @Normann P_ Nielsen _Netic_ , We have a Document Management system App that could suit you well. SoftComply Document Manager It is on the heavy duty side, focusing on regulated industries. Feel free to check it out or arrange a demo. https://calendly.com/softcomply/eqms?month=2025-01 Regards Matteo

Hey, you forgot about us! SoftComply Document Manager More of a heavy duty document management system for regulated industries.

For flowcharts then draw.io. But they are just drawings, they do not have any "task" associated to them (afaik). Otherwise Jira can do workflows too. What exactly are you trying to achieve? Can you make an example?

Then Comala will definitely do. Matteo

Hello @Ralf Schmelter There are several Apps that have workflows and electronic signatures. Depending on the specific application you may want to look into different ones. Are you looking for generic workflows for pages, with or without signatures, or something more complex for regulated industries? Matteo

Hello @Lois Goodsell , We have an App (on Confluence Cloud) for Document Management designed around 21 CFR 11. SoftComply Document Manager You can try it for free, full features for 30 days. We also have other Apps for the MedTech industry, see link below: https://marketplace.atlassian.com/search?query=softcomply Feel free…

Hi, Not that I am aware of. We recommend to our MedTech customers to either have a "header" and "footer" pages and bring the info in with the "include page" or "include excerpt" macros, or go with something like Scroll PDF exporter which has everything. Matteo

Hi Erik. For Confluence ticking a box or completing a task is considered a change in the content, and Comala behaves accordingly. You can either lists tasks in a subpage and then include (use the include excerpt macro) this into the main page, of "freeze" the content of the page (it will show incomplete tasks, but this was…

Hello @Katherine Lord , We have a Change History Table App for Comala Document Management that reports the approvals inside the page and also works in published pages, see https://marketplace.atlassian.com/apps/1228268/softcomply-change-history?hosting=cloud&tab=overview if interested Matteo

Hi @Premal Doshi, There are several Apps that provide workflows, depending on how simple/complex your requirements are. We have our own for Confluence Cloud, if you want to give a look at it: SoftComply Document Manager. Matteo

Hi @Hallmark Surgical QMS The simplest by far would be to create a process in Jira. You can set up a workflow that matches your process, set up the issue fields per your requirements and add conditions and transitions as necessary. Otherwise you can do it in Confluence, but you will need Apps to add workflows to it. In…

HI @Oliver Eidel , There are a few Apps in Confluence that do electronic signatures but admittedly not many with proper versioning. Scroll Documents is one of the few. For our customers we initially had to create a dedicated App for Comala to report the Change History Table inside the page, with independent versioning.…

Hi, We ahve a free App that has a macro exactly for this: https://marketplace.atlassian.com/apps/1229624/softcomply-toolbox-for-confluence?hosting=cloud&tab=overview Matteo

Hello @Barbara Acker Yes it is possible, but you will need some Apps to add key features, such as versioning, change history table, permission management and more. There are several Apps in the Marketplace for this. We have ours SC Document Manager. It was designed for compliance to ISO 13485, which is the MedTech…

@Brian L Pate absolutely right, I found FTAs incredibly useful in the decision making process. It gives you a solid, risk based rationale to justify it.