Regulatory Open Forum

Hello,

Can anyone recommend a good software program for implementing/maintaining FDA QSR and ISO 13485 requirements?  I'm looking for one either with or without project tracking capabilities. 

Thank you!

I am wondering about the same thing.

I could find a software to run the quality system but not to install one.

I guess a detailed spreadsheet will be the most effective since there is not much that a software can do for the implementation!

Does your firm employ SharePoint in any format? I have built our entire system (Quality, etc.) on SharePoint online. I've written our LIMs connected to it as well.

There are many project-oriented tools available in SharePoint, including Gantt charting. The online version works so well with Office365. I've "part-11" provisioned it as well. Audit trails, user-roles, etc.

We also employee SmartSheets when collaborative spreadsheets are required.

Have a great day... I'm happy to help w/ any questions about either system if you have them!

I follow a podcast / blog like greenlight guru and they pitch their software, which I believe is for this purpose. They also have very good content on their blog / podcasts.