Correction fluid found on documents that are reviewed

[Jim Wynne]

What seems to be missing here is some sort of controlled method for correcting errors in records. There have been discussions here in the past where it was suggested that records should never be corrected or altered, but that makes no sense. Where there are errors or misstatements in important records, they should be corrected. What's needed is a written procedure that describes acceptable methods, along with roles and responsibilities. You always have to be on the lookout for instances where records have been falsified, of course, but it's really important to codify acceptable methods for making corrections and provide swift discipline when the rules are broken.

 

[gpalow]

I would open a CAPA and say something to the effect "we found correction fluid being used. we do not want that at this facility. we will inform purchasing that none is to be bought. GDP SOP will be updated to say no correction fluid. All employees will be trained on new GDP SOP. Any correction fluid found will be disposed of." Maybe write and exception deviation for the use of the correction fluid tracing to the CAPA or just note the CAPA directly where the correction fluid was used. -Matt

I pretty much did exactly what you have said. Thanks for the great feedback!