Matteo Gubellini [SoftComply] Expert

Hi Aaron, Regarding the increased "exposure" of population to risks due to product adoption, I saw companies use different probability scales depending on the forecast number of users, e.g. "Improbable" was 10^-6 for "normal" usage, but 10^-7 for "high" usage. But here we were talking about 100k's of users.

Hello, We have also developed our Document Management App, but it is more advanced than Comala Document Management/Control. It depends on what level of complexity you are looking for. Please check SoftComply Document Manager if interested! Matteo 

Hi, Good to see you can now apply e-signatures to pull requests. So far our customers had to create an export of all of them at the end of the project and approve them in a separate document. The FDA was ok with it, but it was far from ideal and not fully compliant if you ask me. Signatures should be concurrent to the…

Hello @Matthew East We have an App specifically designed for QMS documentation management: SoftComply Document Manager It creates separate spaces for QMS documentation, so your compliance team can only focus on these, while for the rest of the instance is business as usual. The compliance team can prevent the use of…

Hello @Sana_Iqbal , The page ID is taken directly from Confluence and cannot be modified unfortunately. Matteo

Hi @Mykhailo Pavliuk, I agree with Marc above that the out of the box Confluence is not very strict and lacks a lot of basic features like workflows and proper electronic signatures. Approval by checkbox is not advisable and can be challenged from a legal standpoint. Comments are better but still quite weak. We work with…

Hello @Chris , With QMS you mean for managing procedures, records, etc? Matteo

Most services are down... Outage level: Elon Musk

Hello @Prashant Ambawale , Without Apps there are no Workflows nor Electronic signatures in Confluence. Regards Matteo

Hi @Prashant Ambawale We have a solution based on a number of Apps and specific customization to make Confluence a 21 CFR 11 compliant document management system. Without Apps there are no workflows, electronic signatures or proper reporting. Feel free to get in contact with us if you want to explore it @…

Hello @Jean Ann Harrison , As far as I know, there is no publicly available Validation documentation for Jira. We are working on providing a self-validation app for our tools (and thus validating some of the underlying Jira features), and we already have one for Confluence, but nothing for Jira itself at the moment. We'll…

It seems they fixed the issue, can someone double check?

Hello, We have recently released a new App for Confluence Validation App . This App runs a set of tests in the background to ensure that the integrity of Confluence is maintained, and creates an automatic protocol and report. Matteo

Bug ticket created. Please vote if you are affected. https://jira.atlassian.com/browse/CONFCLOUD-75444

Yes you have to add it to each page. The sky is the limit (sort of) for user macros. You can create them yourself or ask around. Matteo

Just create a new User Macro with the following code: ## @noparams $content.Id

Ah, ok, this was for cloud. Let me check if we have a custom macro for it.

It's a free app now with some more stuff. Please note that there is an Atlassian bug where the inline version does not export to PDF. SoftComply Toolbox Matteo

ok, I opened a ticket with Atlassian, we'll see.

Hello @Claes Jacobsson , You need to install an App only once in an instance, then all users will have access to it. Matteo

Hi @Finu Augen , We have just released a free app that can embed the last modified date in the page. This can be used with the page property macros as above, but you don't have to enter it manually. https://marketplace.atlassian.com/apps/1229624/softcomply-toolbox-for-confluence?hosting=cloud&tab=overview The property name…

Hi, A bit over time, but we have just released a free up that has this feature https://marketplace.atlassian.com/apps/1229624/softcomply-toolbox-for-confluence?hosting=cloud&tab=overview Regards Matteo

Also please check this blog post: https://softcomply.com/how-to-maintain-a-documentation-baseline-in-confluence/ Matteo

Hi @cyrille_guillard , We have an App that does something like this, but it is for Confluence. It basically freezes the content of a Jira report in a page. I'm not sure this is exactly what you are looking for, nevertheless the link is below.…

Hi all, I'm not sure how much information you'll be able to get from Atlassian, but the FDA has just released a new guidance document https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software that may give you some directions. Matteo

@Dirk Ronsmans @Fabio Racobaldo _Catworkx_ Thanks for the links, but I'm probably missing something. I can't find the setting to verify a domain, see pic below.

Hello Amit, We recommend our customers Comala Document Management + Comala Publishing. This is more or less the best you can get on Confluence Cloud. 13485 is not a problem, the real challenge is 21 CFR 11. There are some small gaps in the Cloud products, such as the fact that they keep on getting updated without your…

Hi @Talya Yurman , This depends on what test cases you are planning to run regularly and what you use Jira for. Our recommendation is to complete a full, deep validation at the beginning, then run only a subset of test cases to confirm the original validation is still valid. Many of our customers perform it every 3-6…

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Hello @Talya Yurman , Yes this is a problem for Atlassian Cloud products. We recommend our customers to perform an initial thorough validation and then repeat a subset at certain intervals. You can use a risk-based approach and justify the use of SaaS like this. As far as I know our customers did not have any issue…