21 CFR 820 Record Control Requirements

M

Mark75

#1
Hello -

I'm looking for input about whether or not the following situation is considered a violation of 21 CFR 820.70, 820.80 and Good Documentation Practices in general. Here is the scenario -

The following information is being documented:
- Lab test results are recorded in non-controlled lab notebooks
- Some process parameter checks, such as oven temps and other equipment settings, and times for when these recordings were taken for each batch are recorded on non-controlled forms
- Quantities of product produced & scrapped are recorded on a blank sheet of paper

Then at a later time, perhaps at the end of each shift, or maybe even the next day (who really knows), this information is being entered into a validated Excel spreadsheet. The person entering the information isn't the same person that is recording the results. Then the above records are thrown away (not sure about the lab notebooks yet) after the data is inputed and not maintained in the DHR. The spreadsheet is the only thing that is printed out and maintained in the DHR.

This is not a closed system where data is immediately fed into the validated spreadsheet and the data is not automatically captured by any validated software. However, I was informed that the spreadsheet is validated as justification for recording data in this manner.

I'm not an expert when it comes to 21 CFR Part 11 compliance, but my opinion is that you still need to follow 21 CFR 820 record keeping req's and Good Documentation Practices. I definitely feel this is a compliance risk.

Is this even debatable? Whether or not the spreadsheet is validated when it's done this way my experience tells me "no".

Regards,
Mark
 
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Stijloor

Staff member
Super Moderator
#2
Hello -

I'm looking for input about whether or not the following situation is considered a violation of 21 CFR 820.70, 820.80 and Good Documentation Practices in general. Here is the scenario -

The following information is being documented:
- Lab test results are recorded in non-controlled lab notebooks
- Some process parameter checks, such as oven temps and other equipment settings, and times for when these recordings were taken for each batch are recorded on non-controlled forms
- Quantities of product produced & scrapped are recorded on a blank sheet of paper

Then at a later time, perhaps at the end of each shift, or maybe even the next day (who really knows), this information is being entered into a validated Excel spreadsheet. The person entering the information isn't the same person that is recording the results. Then the above records are thrown away (not sure about the lab notebooks yet) after the data is inputed and not maintained in the DHR. The spreadsheet is the only thing that is printed out and maintained in the DHR.

This is not a closed system where data is immediately fed into the validated spreadsheet and the data is not automatically captured by any validated software. However, I was informed that the spreadsheet is validated as justification for recording data in this manner.

I'm not an expert when it comes to 21 CFR Part 11 compliance, but my opinion is that you still need to follow 21 CFR 820 record keeping req's and Good Documentation Practices. I definitely feel this is a compliance risk.

Is this even debatable? Whether or not the spreadsheet is validated when it's done this way my experience tells me "no".

Regards,
Mark
Anyone to help Mark?

Thank you!

Stijloor.
 
M

MIREGMGR

#3
...you still need to follow 21 CFR 820 record keeping req's and Good Documentation Practices.
That statement of course is true.

As you've described the situation, I agree with your conclusion, assuming that this data is related to a process for which data retention is required.
 
M

Mark75

#4
Thank you very much for some feedback. :thanx:

Yes, the recorded information all pertains to mfg process parameters and lab test results (also in place to verify product quality and conformance to spec req's). I figured this was pretty cut-and-dry, but 21 CFR Part 11 was thrown in as a potential justification, so I just wanted to gain feedback from others.

If anyone else happens to have any feedback please feel free to share.

Thanks,
Mark
 

Ajit Basrur

Staff member
Admin
#5
Hello -

I'm looking for input about whether or not the following situation is considered a violation of 21 CFR 820.70, 820.80 and Good Documentation Practices in general. Here is the scenario -

The following information is being documented:
- Lab test results are recorded in non-controlled lab notebooks
- Some process parameter checks, such as oven temps and other equipment settings, and times for when these recordings were taken for each batch are recorded on non-controlled forms
- Quantities of product produced & scrapped are recorded on a blank sheet of paper

Then at a later time, perhaps at the end of each shift, or maybe even the next day (who really knows), this information is being entered into a validated Excel spreadsheet. The person entering the information isn't the same person that is recording the results. Then the above records are thrown away (not sure about the lab notebooks yet) after the data is inputed and not maintained in the DHR. The spreadsheet is the only thing that is printed out and maintained in the DHR.

This is not a closed system where data is immediately fed into the validated spreadsheet and the data is not automatically captured by any validated software. However, I was informed that the spreadsheet is validated as justification for recording data in this manner.

I'm not an expert when it comes to 21 CFR Part 11 compliance, but my opinion is that you still need to follow 21 CFR 820 record keeping req's and Good Documentation Practices. I definitely feel this is a compliance risk.

Is this even debatable? Whether or not the spreadsheet is validated when it's done this way my experience tells me "no".

Regards,
Mark
I agree Mark. 21 CFR part 11 is a distant non compliance but the example cited seems to be non compliance from 21 CFR Part 820.
 

Al Rosen

Staff member
Super Moderator
#6
Although I agree the practices are not the best, for the sake of discussion, what specific requirement is being violated? I can't seem to find one.
 
M

MIREGMGR

#7
what specific requirement is being violated?
Assuming as above that this data is related to a process for which data retention is required, the recordkeeping requirement would be inferred from 820.70 Production and Process Controls.

It's a reasonably standard inference, I think, that for processes that affect the conformance of products to specifications, recording of process parameters is an essential element of controlling that process and preventing deviations.
 
M

MIREGMGR

#9
Aren't they meeting that requirement by noting the data on a "scratch pad" and then entering it into excel?
I think again that that depends on "assuming as above that this data is related to a process for which data retention is required".

For instance, a validated process, per Section "Documentation" of the "Medical Device Quality Systems Manual", Part 4 "Process Validation".

The rule actually states that a signature and date is required from the individual(s) approving the validation, but that's been interpreted in the past to mean that when multiple individuals collect data on which the validation depends, and no single individual can verify the collection of all the data, all such individuals must sign and date.

We've been gigged before for not having such an auditable retention of the original data collection records, with dated physical signatures, in an instance where we had transcribed too-informally collected data into a single record.
 
G

gar4guv

#10
The following information is being documented:
- Lab test results are recorded in non-controlled lab notebooks
- Some process parameter checks, such as oven temps and other equipment settings, and times for when these recordings were taken for each batch are recorded on non-controlled forms
- Quantities of product produced & scrapped are recorded on a blank sheet of paper

Then at a later time, perhaps at the end of each shift, or maybe even the next day (who really knows), this information is being entered into a validated Excel spreadsheet. The person entering the information isn't the same person that is recording the results. Then the above records are thrown away (not sure about the lab notebooks yet) after the data is inputed and not maintained in the DHR. The spreadsheet is the only thing that is printed out and maintained in the DHR.
As I see it, this goes against the requirement 820.40. The noncontrolled lab books are being used to collect information that goes into the DHR. Since we know that a DHR is required, and 820.40 says to control all documents that are required, I would conclude that the lab notes should become part of the DHR. Therefore they should be controlled...or not used at all.

These are the 483s I've seen written regarding noncontrolled docs being used on the manufacturing floor or in a qc lab,

Documents that were not approved were observed at a location where they are being used. Specifically, (insert specific evidence)

and that one is almost always followed by,

Document control procedures were not [complete] [implemented]. Specifically, (insert specific evidence)

Sec. 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

(a)Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.
 
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