Medical Device Documentation

Hi Nadia

I would take a look through our online 21 CFR Part 11 WhitePaper on our website. In addition, we have a blog about configuring SpiraPlan for medical device use - https://www.inflectra.com/Ideas/Entry/configuring-spirateam-for-testing-in-validated-env-548.aspx

Lastly we have a webinar on the subject as well: https://www.inflectra.com/Ideas/Entry/how-to-accelerate-software-testing-validation-1011.aspx

In terms of document management. In additional to managing the requirements and test cases themselves using electronic signatures (as described in our blog and whitepapers), you can generate reports in SpiraPlan (e.g. Requirements Detailed Report) and upload them into the Documents section of the application as well (we will streamlining this process in a future version).

From there you can use the Document Management workflow, check-in/check-out and electronic signature option to control those documents as well.

I hope that helps.

Regards

David

Thank for the information, David - much appreciated.

I'm asking a slightly different question than part 11 and validation, though...just curious whether other folks are using an external Doc Management System with SpiraPlan.

Hi Nadia, you may have had this question answered. We use Spirateam with an external software based QMS document management system. This system currently tracks all non-software related requirements, test cases. However we are moving all of our design related artefacts - requirements, test cases and test results into spirateam this year as it has removed a huge amount of documentation overhead from our small team. Process documentation will remain external but any product and planning related elements will exist in Spirateam and be reported out as needed through custom reports created in Spirateam. We have also moved all company planning into an agile process that leverages spirateam tasks and releases. 

Hey Nadia,

You probably already set up Spiraplan, but maybe you're still interested in how other Medical Device companies use it... We use Spiraplan in conjunction with Sharepoint as a DMS (since management clings to it, we do not use Spira to store the documents). Our view is that everything in Spira is 'work in progress' or 'draft' and at release time, we consolidate everything by creating customized reports that are formally authorized and stored in Sharepoint, and they also end up in our DHF. 

Our long-term goal is to be able to generate a good  portion of our DHF by the data stored in Spira. Ideally, we will hook this into our development pipeline and we can autogenerate a DHF 'on the fly' as the last step in  our devops cycle (where it was previously handcrafted and sometimes took weeks to complete). 

Finally, we also find Spira very helpful for handling external audits, since it makes the whole development process completely transparent and navigable, much easier than leafing through pages of documentation to find that missing trace...