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324 results found for "Lean"

  • What is Management of Change

    Changes made during the product life-cycle can lead to re-validation and conducting more clinical trials provided before the change is implemented; g) provide procedures for emergency changes including a means

  • If Opportunity Doesn't Knock, Build a Door

    This is at the heart of what it means to be proactive and the catalyst for operational excellence initiatives Both of these lead to increased stakeholder trust.

  • IS EDM DEAD?

    Leading vendors at that time advocated doing away with classification schemes. critical problem with using these technologies is that they assume that the data is self-describing which means

  • 5 Multipliers To Increase Compliance Advantage

    However, this audit-fix cycle while insufficient to address compliance gaps, also leaves companies vulnerable This means that you need some sort of force multiplier to provide, instead of a mechanical advantage,

  • Confessions of a QA Manager

    I hope we get a chance to learn from what happened.

  • Can You Trust AI?

    If you made it this far, you may be interested in learning more about this topic.

  • Do You Need A Different System For Each Regulation?

    How this is done can often lead to a duplication of effort and resources all of which contribute to waste At the same time, this can and often leads to separate systems each with their own procedures, practices

  • How To Conduct Scoping Interviews to Manage Personnel Changes

    previous position no longer exists or has been redefined) Job transfer (permanent, temporary/acting) Leaving participants Enter this information into the OMOC tracking system and operational risk registers To learn

  • Maintaining Safe Operations

    What leading indicators would let you know that you might not be able to operate safety?

  • Are we there yet?

    Five minutes after leaving the house they would start asking a question which they would not stop asking

  • Does Compliance Hinder Innovation?

    Changes made during the product life-cycle can lead to re-validation and conducting more clinical trials

  • Reducing Compliance Debt Caused by Deferred Maintenance

    Selecting and approving once a year using the entire maintenance budget leaves no contingency to address

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