Are there FDA rules on handling mistakes on paperwork?
Can somebody tell me where there is a rule that states you need to draw one line and initial mistakes on paperwork?
I just replied to the same question that you raised in this rather older thread with the example from BRC, but if you can let people know what standard(s) you're working with then they may be able to direct you appropriately.
I found an old article on the FDA website news section where item 4. states:
What if I make a mistake?
When you make a mistake—and everyone will at some time—here’s how to handle it:
- Correct your mistake.
- Draw a single line through the mistake.
- Enter the correct information close to the mistake.
- Write your initials and date by the new information.
- Correct mistakes as quickly as possible.
- Do not black out, obscure or erase the mistake – the original data must be readable!
- Do not partially cross out mistakes; always draw a line though the mistake.
- Do not use correction fluid, erasers, or tape.
https://www.fdanews....n-entering-data
In general, you will find this rule used across the industry.
The thing is you should not be using white out to hide any writings/recordings and not even scibbling millions of times over it, because it may open a can of worms and it seems fishy like you're hiding something. Also they do state writing shall be legible. it should be clear enough to read. It just makes records transparent to anyone.