21 CFR Part 11 compliance and software validation usage in Design Control

Ricky Abreu

I would like to request if there are MED device users to share their experience while working on  medical device or pharma projects that are related to new product initiative filings requiring regulatory complaince in closed loop systems integration and security. Have you had to prove part  11 and  validation compliance?

Your guidance is appreciated, thanks. Ricky

Greg Hawk

I am not familiar with that particular compliance but I know there are a few hospitals that use Smartsheet (https://www.smartsheet.com/customers).

 

Information on security: https://www.smartsheet.com/security

 

Enterprise security and compliance information: https://www.smartsheet.com/enterprise/security

 

Whitepaper: https://www.smartsheet.com/sites/default/files/Smartsheet-Security-Paper.pdf

Clinical Research Industry User

My company is working through this now.  I would be interested to know if you had success and are using Smartsheet to manage FDA regulated content.

Sharisse Brutto

Following this thread. I am also interested in this