Printer - CSV /Data integrity/21 CFR part 11

[vahid]

Hello everyone,
I would really appreciate your guidance on the following issue:
Some of the devices used in our production and QC processes are equipped with built-in thermal printers that generate printed results. These results are also stored as PDF files on a server.

My question is: If we stop using the thermal printer output and instead print the stored PDF data using a standard external printer, would that be considered non-compliant with CSV (Computer System Validation) requirements or Data integrity or 21 CFR Part 11? If so, could you please point me to the specific clause or requirement that applies?

Additionally, in cases where the built-in thermal printer is malfunctioning and cannot be repaired, and assuming the device is still storing the data correctly in PDF format to a defined, secure path—would printing from an alternative external printer still be acceptable from a compliance standpoint?

Any references to the relevant regulatory requirements or industry best practices would be greatly appreciated.

 

[yodon]

Is there a reason you feel you need to print the data (rather than maintain it in electronic format)?

The system should be validated. Part of validation could be that you demonstrate proper controls over the PDF output file. That keeps you on solid ground should the thermal printer malfunction / be unavailable. (I can't see that printing to a different printer would introduce any issues but you may want to show that as well just for complete coverage.)

There aren't any specific requirements that go to this degree of specificity. As you posted in the Part 11 forum, you're really about as close as it comes (other than the general 'thou shalt validate all computer software used in execution of the QMS' part). It's all about exercising proper control to ensure data integrity.

 

[vahid]

Is there a reason you feel you need to print the data (rather than maintain it in electronic format)?

The system should be validated. Part of validation could be that you demonstrate proper controls over the PDF output file. That keeps you on solid ground should the thermal printer malfunction / be unavailable. (I can't see that printing to a different printer would introduce any issues but you may want to show that as well just for complete coverage.)

There aren't any specific requirements that go to this degree of specificity. As you posted in the Part 11 forum, you're really about as close as it comes (other than the general 'thou shalt validate all computer software used in execution of the QMS' part). It's all about exercising proper control to ensure data integrity.

Hi yodon, I agree with what you said, but one point that comes to my mind is that if I print the data using a different printer, it might conflict with data integrity requirements related to the 'original' record. It could be a bit difficult for me to prove that during an inspection. However, in general, my system is validated, access levels exist, and restrictions are properly defined.

 

[v9991]

specific to this case/scenario;
thermal printouts are primary data; and they are intended to be replaced by pdf prinouts;
the thermal printouts are primary data ( as they are available online, atline ) enabling concurrent review and approvals.,
changing/shifting to an pdf saved to common folder and subsequent prinout, means/implies an offline approach ( atleast at the end of the process ) how do you address that aspect.

this scenario for an stability chamber or autoclave is different than that of an dryer or lyophilizer etc., ; the point is, the utility and utilisation scenario of the data is to be considered during the QRA and change-impact assessment;

generally speaking
rest of the approach is consistent wrt to rest of the data integrity, data quality principles, provided it is subjected to standard steps of (re)configuration,, re-validation ( specific to the change/scope), data / record life cycle, SOPs, audit trail reviews , backup archival etc

 

[Tidge]

I'm popping in to write: Thermal printouts are probably the most unstable form of records. If it isn't background radiation that evaporates them, it will be daylight, ambient heat, handling, etc. that will obscure the results.

 

[v9991]

I'm popping in to write: Thermal printouts are probably the most unstable form of records. If it isn't background radiation that evaporates them, it will be daylight, ambient heat, handling, etc. that will obscure the results.

Yes that is also an important consideration for handling /managing thermal printouts.;
That is the reason why, thermal prinouts are always preserved by immediate xerox of same, so as to ensure availability through the life cycle of same. Similar approach is taken for TLC places in QC laboratory etc.,

 

[ChrisM]

Thermal printouts will degrade over time, often extremely quickly. How are the pdf files produced, automatically by the software or by scanning the thermal printer output? If they are software-generated then why have the thermal print-outs at all?

 

[v9991]

Thermal printouts will degrade over time, often extremely quickly. How are the pdf files produced, automatically by the software or by scanning the thermal printer output? If they are software-generated then why have the thermal print-outs at all?

1. generation of such data enables the process monitoring; for online reviews; pdfs are post-facto .
2. its a different aspect that, why thermal papers at all...https://www.hoinprinter.com/a-news-the-ultimate-guide-to-thermal-printing