Hello, I believe that I read a post on the use of certain types of pens a while back, but I could not find it again. The FDA requirement in 820.180 Records stipulates that "records shall be legible and shall be stored to minimize deterioration" which auditors have interpreted to mean that the writing implement ink cannot degrade over the life of the record. I have found reference to a "felt pen" and similar in FDA webpages, but no EIRs, 483's or warning letters that identify the use of other than indelible ink pens is required. Does anyone have any further insights?

Hello, I believe that I read a post on the use of certain types of pens a while back, but I could not find it again. The FDA requirement in 820.180 Records stipulates that "records shall be legible and shall be stored to minimize deterioration" which auditors have interpreted to mean that the writing implement ink cannot degrade over the life of the record. I have found reference to a "felt pen" and similar in FDA webpages, but no EIRs, 483's or warning letters that identify the use of other than indelible ink pens is required. Does anyone have any further insights?

Welcome to the Cove-

As long as you are not using invisible ink you should be fine.;)
If your auditor identifies that you should be using a special ink you should request a new auditor.

Quoting the requirement "records shall be legible and shall be stored to minimize deterioration" This basically says to use comon sense when storing and maintaining your records and make sure they are ledgible. For example, storing them in a fire/water safe cabinet.

:D

The industry practice is to use Blue / Black and a non water based ink.

I prefer this.
http://upload.wikimedia.org/wikipedia/commons/8/87/Quill_pen.PNG

I guess I will have to chase down a few birds.
Jeff

Thank you for your response. I believe that we are meeting the intent of the regulation. We have even implemented a scanning of older documents in case our file cabinets fail.

:lmao: Good one AL...many years ago the AF inspector at Fairchild Republic insisted all signatures had to be in blue ink so you could tell it was an original. I guess color copiers weren't available in Farmingdale, LI.:applause:

:lmao: Good one AL...many years ago the AF inspector at Fairchild Republic insisted all signatures had to be in blue ink so you could tell it was an original. I guess color copiers weren't available in Farmingdale, LI.:applause::topic:Thanks Mary, I try. BTW, having also worked there for some years, I know that they are a little behind in Farmingdale.

FDA does not care about the color of the ink, just so that it is non-erasable. FDA frowns upon the use of pencils, white-out, or erasable ink. This is because QSR records have to be legible, stored to minimize deterioration and prevent loss, and be retained for at least 2 years (because by law, FDA is required to inspect medical device manufacturers at least every 2 years). Traditionally, due to records being copied, blue or black inks are preferred due to limitations of certain copy machines. However, if your copier can make legible copies, no matter the color ink and you meet 21 CFR 820.180, pick whatever color ink you want.

However, if you are nervous about the ink, records can be scanned and microfiched. However, original records should not be discarded. This is because original records (not scanned versions) need to be examined onsite by FDA. This is so that the FDA investigator can determine whether the use of pencil or white-out was used + original records have to be maintained at least 2 years.:beerdive:

Welcome back Geochaz,

You had not been around for a while and we missed you.