HI,
I have come up across a software that helps in printing of labels. Option is available in the system to define the structure of the template first and then provide data for the fields defined in the template.
This label printing software is also interfaced with a LIMS software and hence a part of the information of a required sample can be imported into the label record (at the time of label data generation) and a part of the information can also be provided manually by the user. Once this label information is submitted to the database, the label data will be available for printing as a label record.
My questions are,
Can it not be said that this label is electronically generated?
Will the printed label not be 21CFR compliant, if on the label no information such as when the label was printed and by whom the label was printed by is not provided on the label and it has only the information provided during the label data generation?
Yes, of course, the label is “electronically generated” but that doesn’t imply it’s an electronic record (if that’s your question).
What aspect of 21 CFR are you specifically wondering about? It’s a big regulation! Please narrow the scope of your question. I don’t know of any requirement that says a label has to contain when it was printed or by whom. I’m on the device side so maybe pharma is different? You lost me on the interface with the LIMS system.
On the surface, it sounds like your printing process and any label verification process would need to be validated. You would also want to validate the softwre that defines the structure of the template.
I assume that your question is for 21 CFR Part 11 compliance.
In the case what you have described the label is generated electronically however it is not an electronic record. The data that goes to the label is electronic, that requires the LIMS to be validated for 21 CFR Part 11 compliance. The recording of the label printing details are required as a part of label control by 21 CFR Part 211.
Label generation & LIMS shall be 21CFR part 11 Complaint or if not 21 CFR part 11 Complaint then Controls / accountablity shall be adequate, appropriate , necessary documentary proofs shall be available
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Requested to all that only relevent material to the original question or subsequent concerns should be posted in that post, else it seems diverting from the core issue.
I don’t know how the Adverse drug reporting is related with label printing & LIMS software… for promotional / Alerts we can have separate post…isn’t it (If allowed as per forum rules)…Administrator to comment !
Any way post is quite old but yet relevent,
Yes label can be stated as electronically generated.
If you want the time stamp requirement compliance of part 11 for sure you have to have the non-editable date & time printed by the system on label.
As an ancillery system to LIMS, printing module needs to be validated & vice-versa.
Part 11 compliance is a huge chapter…evaluate the URS against the part 11.
Last but not the least which label you are generating from business / pateint safety point of view…