M
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'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
