Electronic Records for FDA - Canned computer program for our Corrective Action system

[Aaron Lupo]

I am in the process of implementing a canned computer program for our Corrective Action system. This program will allow us to change it around to fit our needs. My question is if with this program we are able to send e-mails to the responsible person with all the information for the CAR. They in turn would reply to the e-mail and I am pretty sure that we will be able to take these e-mails and make it an attachment to the CAR. My question is would this be ok for the FDA? I know they are very tricky when it comes to electronic records, documents and signatures. They way I see it is that the e-mail is pass word protected so only that person can use there own e-mail. Am I way off base or is there something I am over looking? Any suggestions or comments would be greatly appreciated.

 

[Marc]

I can't comment on the FDA, but for ISO and QS it's OK.

 

[Marc]

Any other takers on this question?

 

[Andy Bassett]

ISO GUY
Cant really help youbut i am interested in your system. In one particular company we have a CAR system set-up on an Excelsheet, the only problem is that the people who need to takr action are simply receiving the complete sheet, and dont seem to have the discipline to take the necessary action

I would prefer a system that gives only the points that are relevant direct to the person.

Anybody any ideas how this can be done?
ISO GUY How do you get your emails to the personnel linked to you CAR system, or is this done manually.

Regards



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Andy B