Kneat: Life Sciences Validation Software Implementation

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Yes, exactly. Who decides what happens if something fails?

I can definitely speak to that as I am currently writing an event procedure. For a large greenfield project, there is often a suite of project-specific procedures that are based on existing site or global documentation. Mature companies like Pfizer and Lilly have gone through this process many times and have existing global procedures. Many sites interpret these procedures in their own way.

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Yes, exactly. Who decides what happens if something fails?

For a brownfield site, there will generally be a suite of existing site procedures that you will base all of your documentation on. However, having your own project-specific procedure can be beneficial for a project team, as their expansion might require doing things slightly differently. This flexibility allows them to manage small details without being locked into a site procedure that may not apply to them.

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Yes, exactly. Who decides what happens if something fails?

When writing an event procedure, it follows the global guidance and key aspects, but is tailored to the project's needs. For instance, we are raising events in a paperless way, which changes our approach compared to how the site would have done things on paper. I am writing that procedure while adhering to global procedures but modifying it to suit our needs.

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