Original Documentation - Need to maintain any original hand written documents

[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!!!

 

[Sidney Vianna]

Re: Original Documentation

Can someone please clarify as to whether this is a legitimate ISO requirement?

No, it isn't.

 

[somerqc]

Re: Original Documentation

No it isn't...err...somebody said that already.

This person sounds like the type that keeps stopping me from starting a consulting business. Bad reputation of consultant's......

 

[db]

Re: Original Documentation

I agree with Sidney. Ask her to "Quote the Shall".

Now, with that said. I would also look at your own documentation. Perhaps the requirement is in there. If so, then either you have to do it, or change your procedure that states it.

 

[db]

Re: Original Documentation

This person sounds like the type that keeps stopping me from starting a consulting business. (

Or perhaps it could be the reason to start......

 

[ddunn]

Re: Original Documentation

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!!!

WHAT??? :mg:

Once a document is approved or submitted and placed under Document Control that is the official version right, wrong or indifferent. The hand written notes no longer matter. Unless the hand written notes you are talking about are such things a test results or other information entered on a official record.

 

[Randy]

Re: Original Documentation

Listen to these guys and then ask the consultant if she understand the definition of "competence"

 

[MIREGMGR]

Re: Original Documentation

We're a medical device maker. We just had an audit of a process validation by a Very Large Global Customer in which we were told that it is mandatory to keep the original data collection records, with original physical signatures.

We are not FDA Part 11 compliant...we do not have an acceptable means of provably/uneditably attaching a unique signature to a computer-created or stored document. The auditor is interpreting certain process validation requirements to call for signed data collection records.

 

[Wes Bucey]

Re: Original Documentation

WHAT??? :mg:

Once a document is approved or submitted and placed under Document Control that is the official version right, wrong or indifferent. The hand written notes no longer matter. Unless the hand written notes you are talking about are such things a test results or other information entered on a official record.

Pretty close! In an FDA environment, especially in pharmaceuticals, the original notes are required to be maintained - no white out or erasures allowed - there is a specific way to mark errors and enter corrections to leave a clear audit trail.

Similarly, for organizations and individuals engaged in R&D, where patents may be sought or defended, the same adherence to maintaining ALL the original documentation may be required.

In all other cases, the decision whether to transcribe or transfer the data to another medium from the original is at the discretion of the organization, tempered by any contracts or specific regulations to the contrary.

 

[JaneB]

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.

Absolute balderdash. (that's English speak for 'trash'.)

I can't speak for FDA, but she most certainly doesn't have a clue what she's talking about re. ISO 9001 (and I'd guess similarly for FDA). But there is, of course, a big difference between an actual record (eg, signed notes, actual data) and the official, now approved version of a controlled document. One needs to be clear about that.

If she didn't carefully explain the difference and ensure it was understood, I'd get rid of her and get a real consultant.

Groan. This is the kind of anecdote which perpetuates the poor view many people hold of consultants. Sheesh.

But yes I agree it's definitely a good reason to start thinking about starting a consultancy. After all, if this were typical of the opposition, there isn't much to worry about!