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

Ricky Abreu
edited 12/09/19 in Archived 2016 Posts

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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