Hi everyone!
My company makes a medical device that uses proprietary software as a major component. We recently found out that an unreleased version of a software test was used on the production floor. Obviously that was unintended and we opened a CAPA. My question is, what is the best approach for controlling software? We have EDMS and Production is supposed to only use software that has been released on the EDMS. The problem is that some of these tests have been downloaded to individual laptops used as test stations and operators are not checking with EDMS to see if the downloaded version is current.
Can anyone comment on how they handle this at their companies? Thank you in advance.
Carol
My company makes a medical device that uses proprietary software as a major component. We recently found out that an unreleased version of a software test was used on the production floor. Obviously that was unintended and we opened a CAPA. My question is, what is the best approach for controlling software? We have EDMS and Production is supposed to only use software that has been released on the EDMS. The problem is that some of these tests have been downloaded to individual laptops used as test stations and operators are not checking with EDMS to see if the downloaded version is current.
Can anyone comment on how they handle this at their companies? Thank you in advance.
Carol