Controlling Software Versions that are part of a medical device

Carol2015

Starting to get Involved
#1
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
 
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Mark Meer

Trusted Information Resource
#2
Welcome to the Cove Carol2015! :bigwave:

Two suggestions:

1. Production
If you maintain/output production records, put a "version installed" field on the form, forcing whoever is installing the software to check and record the version.
Whoever is authorizing release of the units, checks the final completed forms and (among other things), confirms that the version is correct.

2. Documentation/Change Control
Maintain a file/log/spreadsheet of "locations" of the software. If someone is installing on a different system (e.g. for testing/development purposes), it gets logged. Part of the change control/software release process is then to go through all recorded locations, and either purge the old version, or overwrite with the new one.

A third (albeit involved) option would be to design in some automatic check. Assuming network connection, the software could check a single, official, location of the current version and confirm that it is up-to-date every time it is launched.

MM.
 
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