By Anonymous on Monday, January 20, 2003 - 01:40 am:
Hello Together
I am looking official papers which deal with this subject. Internet sources are prefered.
Thanks in advance
By Anonymous on Monday, January 20, 2003 - 08:33 am:
Unfortunately, our QA department brought up this issue a few years ago, and I responded that I felt it was bullcrap, shame that our tax dollars result in feds sitting around a table discussing crap like this. Next they'll specify which hand to write with, and what grip must be used. If this matters to the feds, then this world is truly getting as ridiculous as it seems. I would say that if your company specifies such in an SOP, then you better follow that SOP. Personally, I'd leave out minor details such as this out of SOPs, better to be a little vague than be too specific and have to comply with that SOP. Let them throw me in jail for using blue ink, or better yet, make them prove scientifically that the ink realy is blue, since inks are generally a mixture of dyes.
By benjamin on Monday, January 20, 2003 - 10:33 am:
Dear Anonymous (2 entries above);
This issue is such a minor one that should not be a problem or an SOP matter.Initially it was recommended to use only non-water soluble black inp to sign document under GLP regulations. The idea was that other colors will fade.
Later on the recommendation changed, even though not officially, to use only blue ink because the color will not photocopy well, and then you can say when a document is an original or a photocopy.
I hope this will not go any further, as you have said it, it is getting pretty ridiculous.
Good Luck;
Benjamin
By Anonymous on Tuesday, January 21, 2003 - 05:23 am:
Dear Anonymos 2
for me it was a pleasure to read your comment, because it's always nice to see that others share the same thoughts.
Dear Benjamin
thank you for your input, which makes sence for me.
Best regards
Anonymus 1
By Anonymous on Wednesday, January 22, 2003 - 07:30 am:
some companies are now requiring that things be signed in colors other than black. This is partially because of the new photocopiers. It is almost impossible to tell a copy from an original. If you sign in blue, for example, when you photocopy, it will be obvious which is the original. Whatever you do, you may want to specify in an SOP. I do not believe that the FDA is sitting around worrying about issues like this when they have bigger fish to fry.