Good Documentation Practice (GDocP or GDP) - Labels and Attachments

U

uhohraggy

#1
Every place I have ever been has had the practice of dating and initialing or signing across the interface of a label or attachment within the record (such as a photo, or a printout that gets attached to the record). I've recently encountered someone who refuses to do that, and instead just makes a pen mark (typically a double line) across the interface, and has insisted on training the entire company that way.

1) Has anyone ever seen this practice?
2) If we define it in our GDP SOP would it be acceptable? (It currently is not)

I was always taught the initial and date is to ensure it is obvious if it is removed and/or replaced.

As usual with most GDP issues... any reference to standards, regulations, books, or other authorities on it would be appreciated, but like most, I suspect there are none. (hence why I hate GDP!)
 
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Q

QS_Manager

#2
I have also seen this industry wide in my 30 yrs of experience and am at a company that also doesn't practice this. I haven't found a documented reference but am putting the requirement into our procedures.

How we practice GDP is up to us as long as we meet the general requirements. We use ALCOA as a basis and built from there.
 
#3
Welcome QS Manager :bigwave:

For benefit of Covers, ALCOA stands for Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate
 
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