Correction of records - FAR or DFAR?

[qualitygEEk]

Is anyone aware of a FAR or DFAR which specifies requirements for making record corrections? i.e., don't use correcting fluid, use a single line, sign & date - that sort of thing.

I tried doing a search both on the interwebs and here within the Cove but had zero success at finding anything on this topic. In the past, companies I have worked for had command media specifying the process of record corrections but I'm looking to learn if there was a FAR/DFAR driving that internal requirement.

Thanks!!!

 

[Al Rosen]

There is no single rule that states directly "whiteout may not be used", but the requirement can be found throughout the regulations indirectly. Look at 21cfr122.5 for example. Correction of records - FAR or DFAR?

This information must be stored in such a manner that none of it may be altered once it is initially recorded without recording all changes, who made them, and when they were made.

Whiteout does not allow you to see the original record.

 

[qualitygEEk]

Thanks Al, 21cfr122.5 is for medical devices so not applicable to the business I am in. I believe the requirements for legibility, identifiable, and retrievable in AS9100D would also cover it though not explicitly stated as a thou shalt not use correction fluid, but I was asked specifically about DFAR/FAR requirements.

 

[Eredhel]

I'm in such a habit of single strike through with an initial that I can't break it. But I also don't know if there is a "shall" for that specifically.