Correcting Electronic QMS Records

[Mike S.]

Sorry if this has already been covered, but I didn't see it.

Do any of you have sections in your record/documented information control procedures that specifically addresses corrections made to electronic documents? If so, would you share the gist of your procedure with respect to that?

Our procedure addresses corrections to written/printed records which involves, at a minimum, putting a line through the original entry so it is still legible and writing the correct entry beside that, and then initialing and dating the correction. This is what my last company stated in their procedure as well. But I realized we don't specifically address making a correction to any of the various types of electronic records.

 

[Jen Kirley]

What type of software is the record kept in? MS Office types could have Track Changes turned on, which keeps track of the change, who makes it and when. Some Adobe subscription types also allow annotation.

Otherwise I guess you could save the updated record under a new name and be sure to keep the previous version too.

 

[Mike S.]

The electronic records could be in various software such as a Word or .pdf doc, an Excel form, an Access database, various different purchased software packages like a "training manager" or a "calibration manager" software program.

I've done what you said with individual files and saved the correction under a new file name in the same folder like "Test Report" and "Test Report corrected", keeping the original.

But I realized we don't have the process for how to properly handle corrections to electronic documents in our control of records procedure, while we do have clear instructions for how to handle written corrections. So I'm wondering how many people address this procedurally, and how.

 

[Jen Kirley]

But I realized we don't have the process for how to properly handle corrections to electronic documents in our control of records procedure, while we do have clear instructions for how to handle written corrections. So I'm wondering how many people address this procedurally, and how.

I don't see people doing this. I suppose your procedure could describe acceptable methods as you did, or else simply state that the previous information shall not be removed, obliterated or otherwise be rendered unavailable for review as needed.

 

[Thee Bouyyy]

Sorry if this has already been covered, but I didn't see it.

Do any of you have sections in your record/documented information control procedures that specifically addresses corrections made to electronic documents? If so, would you share the gist of your procedure with respect to that?

We have simply written in our procedure that "Methodology used to identify changes is by ‘blue color, bold and italic text".

Till now it works for us.