Harmonic Bionics

What other eQMS are missing- Separating conversations from data

Denis Machoka · Harmonic Bionics

In this story

Harmonic Bionics

Denis Machoka pinpoints a critical shortfall in many eQMS: the division of conversations and data. He critiques the inefficiencies of navigating isolated data and scattered emails, championing Unifize's innovative fusion of both. By merging discussions with data, Unifize presents a unified, actionable view, streamlining decision-making and collaboration.

SpeakerDenis Machoka
IndustryMedical Devices
Processes in playDesign History File, Device Manufacturing Record
Runtime2:54

Transcript

13 passages · 2:54
  1. 0:00

    I think the main thing there, the companies or other tools that are out there they're missing, is separating the conversation from the data.

  2. 0:09

    A lot of other systems have a conversational piece which is email and everything else. Then you have the data which is totally isolated. So for you to navigate that, you have to know the system and where the data is located.

  3. 0:21

    Then you have to go and navigate where the message is, which means you have to channel through thousands of emails to try and get the right information that is a lot of time wasted there.

  4. 0:31

    What if and this is why it's just a beautiful tool to have why can’t this be done together? Right. There's nothing say in the regs that you can't do this, So this tool allows for that to happen together, and that's the power of the tool. When you merge the data and the conversation, you have a full picture of the data.

  5. 0:50

    Now you can do something about the data. Now, you can talk about the data now everybody's vision, everybody's concern, everybody's opinion of that data is all documented.

  6. 1:01

    And the beauty of it is you can search on that data, you can do data aggregations on different conversations, and you can find the latest information.

  7. 1:09

    One of the best things that I noticed is how easy it is to get audits, preparations through that I'm able to see the conversations, which means I'm able to know what the latest information is, and that is invaluable. Instead of going through emails, all that information is there right, with the data.

  8. 1:25

    Compared to other systems that manage DHF and DMRs, Unifize brings a very unique addition to that process. One of the unique things is the relationship between the files. So when you have different files, you can tell the relationship between the files.

  9. 1:42

    Some systems you may able to do that, but it's you have to do a little more digging. Not only do you have to do digging, but you also have to know where that file is. You have to dig into the file, see where the relationships are. There's a little more work that is involved.

  10. 1:57

    When you look at Unifize, it simplifies that process because all the files are visible in objects and you're able to open each file and view what is within those files and associated discussions.

  11. 2:09

    That's where the most important part of the whole thing is.

  12. 2:13

    Who added the file, what was added when it was added. So you have a little more history of context. At most other systems like MasterControl and the rest of the other systems, you may find that you may not have that information. You need to go to somebody who did the file, update to the file to give you the context of that information.

  13. 2:31

    Unifize keeps that context. So if you're in an audit or you're being audited, for example, and you want to find out why that file changed the last few months, you have context because that information is still there.

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