If SOLIDWORKS PDM is installed, will it conform to 21 cfr part 11?
Hello yes that is correct.
PDM by itself does not make a company FDA compliant. Rather it's the company's processes and how softwares like PDM are implemented and configured, that is looked at by the FDA during an audit.
PDM does have some features, such as a electronic audit trail, built in security, and double-authentication that can help.
I would ask your VAR for more information.
Thank you immediately answer.
Is the standard function of Solidworks PDM validated?
We are not experienced in FDA audit and we want to shorten development period.
In other words, I am looking for validated PDM software.
Hello, validated by whom?
Generally software itself is not validated as I mentioned in my previous reply, it is the way companies use it, that is validated.
I've attached a technical paper written by SolidWorks some years ago on this topic. Hopefully it helps.
I was sorry if I had misunderstood in poor English.
You are not selling validated PDM at your company.
The buyer of PDM has to decide management rules and the buyer himself needs to perform software validation.
Retrieving data ...