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!!!

Can someone please clarify as to whether this is a legitimate ISO requirement?No, it isn't.

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...... :(

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.

This person sounds like the type that keeps stopping me from starting a consulting business. (
Or perhaps it could be the reason to start......

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.

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

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.

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.

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'.):bonk:

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. :nope::nope:

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!

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!!!

...actually, i have seen the same scenario with one of our supplier....

...it is really bizarre that they have customer that requires them to keep their original handwritten forms...

...I got curios, so I asked why? k, here's I found out... the person who is writing the initial information on the form is different from the person who is encoding the data into the system... and they have complaints regarding the "discrepancies" of the information printed from their system with the original "written" form which have been initially agreed by their customer & company representative...

...so, the only solution to trace where the errors are coming from is to keep the original hand-written records and compare them with the final printed document (if customer complains discrepancy)...

...the point is, try to evaluate first your process if keeping the original handwritten records are really worth thing to do... then join the battle of not requiring them…
:2cents:

Yes, for FDA regulated sectors like medical Devices, Pharmaceuticals, Veterinary Medicine etc, this is a requirement.

The original documentation that you refer is called as "RAW DATA" in FDA terminology. The reference for Raw Data could be found in 21 CFR 58.3(k) and says the following -

Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.

Refer section (k) in - 21 CFR Part 58.3 (k) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=58.3)

This thread has helped me realize 2 things.

1. Definitely get my plans for a consultant business started
2. No wonder my mother-in-law is crazy! She has to deal with the FDA and the Canadian version too!

:)

Sorry I can't of more help; I don't have the "pleasure" of dealing with the FDA.

John

Yes, for FDA regulated sectors like medical Devices, Pharmaceuticals, Veterinary Medicine etc, this is a requirement.

The original documentation that you refer is called as "RAW DATA" in FDA terminology. The reference for Raw Data could be found in 21 CFR 58.3(k) and says the following -

Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.

Refer section (k) in - 21 CFR Part 58.3 (k) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=58.3)This is important to note: when it's required they be kept, the documents can be scanned and kept as e-copies.

As far as ISO is concerned, no way...and it's a darned good thing too! Imagining my handwritten audit notes being kept as real records makes me want to do the Jello wiggle! :lmao:

The only time I feel you need the "Original" is if you are transfering ownership (process owners) signatures (acceptance authority) to an electrical media and you do not have the vehicle to control electronic signatures (AS9100 7.5.3). :2cents:

This is important to note: when it's required they be kept, the documents can be scanned and kept as e-copies.


We have been told that the correct interpretation of the CFR language you quoted in an FDA registered medical device establishment is that either:

1. Each individual scanner page must be printed on paper (to prevent digital editing) and must have permanently affixed to it a statement that the original at time of scanning had no evidence of erasures or whiteout, with each page's statement individually signed by a person with procedurally assigned authority;

2. Or, if the company is Part 11 compliant (i.e. the FDA's rule on electronic signatures and secure electronic data control to prevent and/or detect changes), the data can be stored electronically, with the above attestation of exact copy electronically signed as above.

Trying to make an argument that paper is bad, therefore a regulatory justification will be found to support elimination of paper, is a non-starter for certain data types in an FDA environment.

The key issue is that the 'hand written documents' are not temporary, ephemeral things that are merely steps along the way to getting to the official version of something (eg, version 1 of an agreed & controlled document) but in this case they are actually records.

Thus the importance attached to keeping them.

The logic and rationale for retaining original records is clear. Was this not perhaps clearly explained by the consultant? Or did something go missing afterwards, when the information was passed on?

The OP did not come back for which type of industry she is working with - if its FDA regulated industry, the original needs to retained. No discussions as its a requirement. If non FDA, its optional.

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!!!

The OP never said that the organization was subject to FDA requiremnts, only that the consultant came from an FDA background and may have been misapplying that background to an ISO 9001 audit.

I dont know why people let consultants/auditor/IknowThatBetterGuy tell whatever they wish.

Just ask them, why? where is that written?

If your procedure says that report must be created and maintained for some time, you must do that. No matter is it hand written or not.

The OP did not come back for which type of industry she is working with - if its FDA regulated industry, the original needs to retained. No discussions as its a requirement. If non FDA, its optional.In fact, the OP has not logged in since the time of the first post. There is a possibility he/she has read NONE of our wit and wisdom.

In fact, the OP has not logged in since the time of the first post. There is a possibility he/she has read NONE of our wit and wisdom.

Interesting. I'd assume that if it was a real issue which someone really wanted to get some good information on, this would not be the case. But it makes conjecturing about what might or might not be the case somewhat of a waste of time...

It's even possible that the denigration of said consultant was based on an inadequate understanding (or listening) by the original OP. This too happens, and it isn't always fair or reasonable to go into 'consultants are all hopeless' when it's based on inadequate info.

OK, I'm biased :tg: But there are good, bad and indifferent everythings out there, from consultants through auditors and even (gasp!) quality managers... :tg: