Trial Master File in SharePoint

[rammellconsult]

Any solution - including homegrown ones - would need to be validated. An in-house build would take more effort to validate than an off-the-shelf Sharepoint-based system. However, I have seen in-house Sharepoint systems be validated, as per 21CFR11, FDA guidance on use of computerized systems in clinical trials and the EU guidance "Good Practices for Computerised Systems in Regulated GxP Environments".

[Costello]

I agree with rammellconsult. We have implemented Sharepoint numerous times. I like the analogy of the index dividers and that yiou have indeed created many other types of "index dividers" so the files can be found quickly and efficiently. The beauty of Sharepoint and correct assignment of metadata. I'd be interested to learn more about the homegrown variants of sharepoint deployments though.