Natalie Jones

Why can't one use Excel or Pen & Paper to manage quality at a FDA regulated company

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Natalie Jones

Natalie explains the inadequacy of using traditional methods like Excel or pen and paper for managing quality in an FDA-regulated company. She highlights the limitations of these methods in ensuring compliance, tracking changes, and maintaining data integrity. Natalie emphasizes the need for a more robust and specialized system like Unifize, which can handle the complexities and requirements of FDA regulations more effectively.

SpeakerNatalie Jones
IndustryNutritional Supplements
Processes in playApproval Workflows
Runtime1:24

Transcript

7 passages · 1:24
  1. 0:00

    If you have five products and that's all that your company is making potentially is manageable with an Excel spreadsheet, as soon as you start scaling up or you're making changes to those five products, let's just say you have 20 products, 30, 40, 50, 60, and you're trying to manage everything.

  2. 0:19

    You know, when I first started here, we had this amount of products.

  3. 0:23

    Was it manageable to do it the way we were without any system? Yes.

  4. 0:27

    But as soon as you start finding out that documentation has changed and then you're trying to where are you saving that in the folder? How does everybody know that it's changed? No alerts are going out unless you're sending an email and no one wants a million emails.

  5. 0:44

    I mean, like we've grown so much, it would be impossible to do everything on paper without a quality management system.

  6. 0:52

    If we didn't have Unifize it would create a disaster. We would be back to square one with finding different ingredients, reviewing the documentation, figuring out how ingredients are different or similar to each other, We would have to obtain all of that information, again.

  7. 1:11

    I can't imagine. I think it would be catastrophic. We would have to start from zero with so many different things.

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