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

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

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Comments

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.