Original Documentation - Need to maintain any original hand written documents

[joshua_sx1]

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…

 

[Ajit Basrur]

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)

 

[somerqc]

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

 

[Jen Kirley]

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)

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!

 

[Bob the QE]

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).

 

[MIREGMGR]

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.

 

[JaneB]

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?

 

[Ajit Basrur]

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.

 

[John Nabors - 2009]

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.

 

[ilConsigliere]

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.