Correction Fluid on documents - FDA regulations?

[dmcgriff8]

Where can I find reference to draw a single line through mistakes, initial, and date the entry and the format of how the month, day, and year should be writtend in the FDA regulations?

[Al Rosen]

Originally Posted by dmcgriff8

Where can I find reference to draw a single line through mistakes, initial, and date the entry and the format of how the month, day, and year should be writtend in the FDA regulations?

I don't think that there is a required format for the date. The requirement for not using whiteout is not stated in the regulation, but they state, {the records} "shall be legible".

[Statistical Steven]

Originally Posted by Al Rosen

I don't think that there is a required format for the date. The requirement for not using whiteout is not stated in the regulation, but they state, {the records} "shall be legible".

You also have to show that the record is not altered (white out or eraser). Most companies go overboard based on previous audits from the agency. For example, only using blue ink because you can tell an original from a copy.

The single line through a change is a procedural issue that is accepted by the industry to show when a record was changed, who changed it and when. This is part of the audit trail that is required.

[Coury Ferguson]

Originally Posted by Statistical Steven

You also have to show that the record is not altered (white out or eraser). Most companies go overboard based on previous audits from the agency. For example, only using blue ink because you can tell an original from a copy.

The single line through a change is a procedural issue that is accepted by the industry to show when a record was changed, who changed it and when. This is part of the audit trail that is required.

I agree with Steven on this one. Try thinking like a customer would. Hmmm...was this record altered? Are the new changes accurate? Why hide something?

At least the single line with the initial and date of the person making the change would reflect that there was nothing to hide.

As for the "Blue" ink. I prefer to use the Blue ink verses black for the simple reason as Steven said "For example, only using blue ink because you can tell an original from a copy."


Coury Ferguson
Program/Contracts Manager

[Aaron Lupo]

Using whiteout is not a good practice and the FDA does not like it. As far as the black/blue ink issue, years ago it was industry practice to use black ink only as blue ink did not photcopy as well, this is not the case anymore. I would also discourage using pencil to complete records as well.

[QualityPhD]

I used to think, ink is ink... until auditing recently and "discovered" the ink in gel pens is NOT water/liquid resistant.

For instance, in a laboratory setting, a gel pen is used to record data, the sheet gets wet... gel pens run, much like a "magic marker"... ergo, record not legible.

On a recent audit of a maintenance facility, they got a "great deal" on gel pens from a supplier of MRO stuuf... Unfortunately, many mechanics complete the paperwork and have lubricant, etc. on their hands that transfers the the "records"... many records contained data that was not legible due to the smearing/smudging of the "on sale" gel pens (which I prefer as they write so well)...

Food for thought...

[Aaron Lupo]

Originally Posted by QualityPhD

I used to think, ink is ink... until auditing recently and "discovered" the ink in gel pens is NOT water/liquid resistant.

For instance, in a laboratory setting, a gel pen is used to record data, the sheet gets wet... gel pens run, much like a "magic marker"... ergo, record not legible.

On a recent audit of a maintenance facility, they got a "great deal" on gel pens from a supplier of MRO stuuf... Unfortunately, many mechanics complete the paperwork and have lubricant, etc. on their hands that transfers the the "records"... many records contained data that was not legible due to the smearing/smudging of the "on sale" gel pens (which I prefer as they write so well)...

Food for thought...

Gel pens or "ink" of any kind that can bleed thru or smeer on a document is not allowed in the medical device arena.