L
Lindsey - 2008
Hi All,
We had a consultant come in the other day and review our Control of Documents SOP. Her only comment was that we need to maintain any original documents that may have been hand written. Basically, she was saying that anything which is hand written and then typed or cleaned up prior to approval or submission needs to be kept. For example, if you take data by writing it down and then entering it into the computer system, the hand written must be kept. I have never heard of this as an ISO requirement and when I asked her whether it was an FDA requirement (she used to work for the FDA) or an ISO requirement, she replied it was both.
Can someone please clarify as to whether this is a legitimate ISO requirement?
Thanks!!!
We had a consultant come in the other day and review our Control of Documents SOP. Her only comment was that we need to maintain any original documents that may have been hand written. Basically, she was saying that anything which is hand written and then typed or cleaned up prior to approval or submission needs to be kept. For example, if you take data by writing it down and then entering it into the computer system, the hand written must be kept. I have never heard of this as an ISO requirement and when I asked her whether it was an FDA requirement (she used to work for the FDA) or an ISO requirement, she replied it was both.
Can someone please clarify as to whether this is a legitimate ISO requirement?
Thanks!!!