I am looking for recommendations for document control software to handle solidworks documents. We are a medical device manufacturer so we fall under FDA regulations as well as ISO compliance. We are currently using DBworks. Has anyone gone through software verification with DBworks?
Any information or opinions are welcome
Thanks
What issues are you having?
TOP
I am looking for software that will be FDA 21 CFR part 11 compliant for electronic records and signatures. Whatever software I use, it will have to be validated that it does what I need it to do and then revalidated every time a new revision of software is released. I am just wondering if anyone out there has done this with DBworks or if there are any other document control packages people have experience with.
DBWorks is compliant to FDA 21 CFR part 11, it has been for years and I have been told will always be.. You just need to set up your standard processes within your organization to take advantage of its functionality. you should contact the DBWorks users group and find other medical companies.
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