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Label Printer Software

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by sksanstuff, Feb 28, 2016.

  1. sksanstuff

    sksanstuff New Member

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    We are having discussion about possibly adding medical devices to our product portfolio and what are the start-up costs. We already validate several pieces of equipment. One area we need help with is validation of our label printers.

    I have researched hundreds of pages and included the FDA website. I know which parts of the CFR's and ISO 13485 have guides and outline for these requirements. Where can I find a completed software protocol as a reference to help get started?
     
  2. QAengineer13

    QAengineer13 Member

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    I am not clear as to what exactly is your previous validation of equipment means? From the little I understand from your post is that you need some guidance related to Label Printer Software, if this assumption is correct, the first important things is the assessment of the intended use/Intended purpose of the Label Printer? is the Software used as a component,part or accessory of a medical device (or) is software thats is itself a medical device (or) is software used in the production of a device (or) is the software used in the implementation of the device manufacturer's quality system, IF THE ANSWER FOR ANY OF THE ABOVE STATEMENT IS TRUE then you need to validate the software used in the Label printer.

    The most important second question is that if software solution for the label printer a "OFF-THE-SHELF (OTS)" Software? I have attached three guideline to help you with this process of OTS & software validation guidelines , after reviewing the guidance,let me know if there are any specific question you have related to software validation ...I will try my best to help you out!
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

    Atul Khandekar likes this.
  3. Candi1024

    Candi1024 Well-Known Member

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    I would assume the label printer prints the UDI labels for the medical device.

    Would you be referring to IQ/OQ/PQs of the printers, or validation of the software?

    I'm not sure that we do any of that on our printers at the moment. Though we are in the process of going through and ensuring IQ/OQ/PQ is completed on the equipment as necessary. I would say ensuring a clean, readable label is produced would be important. We do however inspect and scan every label to ensure readability.
     
  4. sksanstuff

    sksanstuff New Member

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    Thanks for the responses. I have the FDA guidelines.

    For class II devices we need to validate the software used for printing labels. I am looking for examples or guidance to get started. We have done IQ, OQ, & PQ for equipment. I am not sure what the label printer validation plan would look like. What outputs do I check, do I run all labels and do a "PQ"-like documented event...

    Other software you hit a button and you have a specific outcome, or you dont, and you write a document/plan to test that outcome. What if you have 300 different labels, do you run all of them in a validation? What if you add labels later...

    I hope I am overthinking this.
     
  5. yodon

    yodon Active Member

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    No, you don't have to test all 300 label types. You can take identify label types that provide the biggest 'challenge' (largest / smallest label size, largest / smallest font, most complex graphics, etc.) to verify and assert that if these 'edge' cases work, you have a high degree of confidence that everything in between will work.

    I can't share a protocol but I can share some thoughts:
    • You'll want to show adequate protection for the label templates. This is typically a function of the software but if not, should be addressed. Often, there are "label designer" roles and "label printer" roles.
    • Presuming the software takes inputs like dates, lot numbers, etc., you should test for input completeness, range checks, etc. Some of this can be mitigated by a post-print inspection but if the software supports it, you should show it (better to catch in the software than to rely on visual inspection)
    • Probably a good idea to do a software IQ like exercise. Confirm it's operating on the intended equipment, has the latest version, investigate any known issues and document why they're not a concern / how you avoid the situation
    • There may be some back-end software (databases) the software uses; this should be addressed as well, in the IQ (installed properly, any known compatibility issues, etc.)
    • If the software controls printing, counts can also be important. Ensure it supports the min/max expected.
    • If the software controls printing, assess what happens in fault conditions (label tape breaks / runs out, power loss, etc.)
    Depending on the criticality of the labels, maybe not all of the above need be applicable. As you're venturing in to devices, you'll often see that decisions need to be risk based. Determine where you have potential risks and scope actions accordingly. For example, if you're printing an expiration date on the label and someone could be harmed if that date were incorrect, you'd want to focus more attention on the date. If you're printing thousands of labels at a time, good print quality from start to finish and effects of interruptions are probably quite important.
     

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