Matteo Gubellini [SoftComply] Expert

Hi Sachin, yes that's the right direction, but we are looking for something that also records non-admin actions.

Hi @Muhammad Fahad , we have created a workflow with electronic signatures using Comala Document Management for Server. There is a similar version on cloud too. The downside is that you cannot link the completion of fields with transitions, but you have electronic signatures which I don't think are available on Jira.

Hello @Muhammad Fahad , we have built something similar on Confluence if you are interested. It does not follow the exact 8D method, but it can be adapted to the purpose. Regards Matteo

@MB , Could you please contact us at info@softcomply.com? I'm not able to find your direct email. We can then have a call and see what the best solution for you is. Matteo

Hello Glen, We have some experience in the validation of Atlassian tools, but not for Bitbucket in particular. Anyway we can help you in defining the approach if you like. Matteo

Hello @Sébastien CORSYN , MediCompli is not an add-on per se, it is a collation of Confluence add-ons, on a Confluence Server instance on AWS, externally managed and configured to be fully 21 CFR 11 compliant. It's for companies who don;t want the burden of managing a server and need this level of compliance. Unfortunately…

Hello everyone, We have recently launched a service to provide a fully 21 CFR 11 compliant turnkey solution based on Atlassian tools. Check this if you are interested. https://softcomply.com/medicompli/ We can also help you set it up yourself in your own server instance if you prefer. We also have different Apps for Risk…

Hello Vanessa and everyone else, We have recently launched a service to provide a fully 21 CFR 11 compliant turnkey solution based on Atlassian tools. Check this if you are interested. https://softcomply.com/medicompli/ We can also help you set it up yourself in your own server instance if you prefer. Matteo

Hello everyone, We have recently launched a service to provide a fully 21 CFR 11 compliant turnkey solution based on Atlassian tools. Check this if you are interested. https://softcomply.com/medicompli/ We can also help you set it up yourself in your own server instance if you prefer. Matteo

Hello Steven (and others), We have recently launched a service to provide a fully 21 CFR 11 compliant turnkey solution based on Atlassian tools. Check this if you are interested. https://softcomply.com/medicompli/ We can also help you set it up yourself in your own server instance if you prefer. Matteo

Hello everybody, We have recently launched a service to provide a fully 21 CFR 11 compliant turnkey solution based on Atlassian tools. Check this is you are interested. https://softcomply.com/medicompli/ We can also help you set it up yourself in your own instance if you prefer. Matteo

@Margus _SoftComply_ Can you please suggest Sebastien some test tools? Margus is our certified Atlassian Expert and has knowledge of these tools.

Hello Sebastien, We have a Risk Management plugin that can definitely help with the traceability between Risks and Requirements, then you can pull the data in Confluence. Look for "Risk Manager" in the Atlassian Markeplace. A QMS is something that you will probably need to have, and our eQMS can do the job. If you are…

Hello @Mikael Sandberg , Yes, typically backup and data retention are considered part of the software tool validation. 21 CFR 11 explicitly lists this requirement. Having said that, if you did validate the backup function as part of the IT infrastructure, then it should have been enough. Personally I often test the backup…

Hi Steven, If you need to be Part 11 compliant you need an addon that will prompt you to enter the pw (at a minimum) for every signature. The requirements of Part 11 are actually relatively straightforward but you need to be sure you tick all of them. Let us know if we can help any further.

Hello Bhupinder, Confluence can be used as a document management system for your QMS or the technical documentation. Jira can be used as requirement management system coupled with BitBucket, Bamboo and other tools. Jira will manage the workflow and the traceability to requirements. Jira is anyway so flexible it can be used…

Hi Arnold, We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview It contains full guidance for FDA's 21 CFR compliance Regards Matteo

Hi Steve, We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview It will contain answers to most of your doubts. Regards Matteo

Hi Oliver, SoftComply has developed a risk management add-on for JIRA Cloud users that is fully customizable - https://marketplace.atlassian.com/plugins/com-softcomply-riskmanager-cloud/cloud/overview For more information, please do not hesitate to contact us at info@softcomply.com / www.softcomply.com Kind Regards Matteo

Hi Arianna, We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview Regards Matteo

Hello Georgina, We have just released a risk management plugin for JIRA https://marketplace.atlassian.com/plugins/com-softcomply-riskmanager-cloud/cloud/overview Kind Regards Matteo

Hi Peter, We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview It contains full guidance for FDA's 21 CFR compliance Regards Matteo

Hi KP-11, We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview It contains full guidance for FDA's 21 CFR compliance Regards Matteo

Hi Paul, We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview It contains full guidance for FDA's 21 CFR compliance Regards Matteo

Hi Benjamin, We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview It contains full guidance for FDA's 21 CFR compliance Regards Matteo

Hi jatabatabai We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview It contains full guidance for FDA's 21 CFR compliance Regards Matteo