Commissioning

Sequence – MC to PQ

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What’s the sequence of milestones from Mechanical Completion to Performance Qualification? “The whole is greater than the sum of its parts.” This profound observation by the great Greek philosopher Aristotle holds true for biopharma or any project. A successful project is indeed so much more than the achievement of individual milestones like mechanical completion, commissioning […]

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System Boundaries

Commissioning /

How to draw sensible system boundaries? System boundaries are total fiction, but they matter in a project. If not defined at all or not defined correctly, these boundaries can fuel a good deal of confusion in a project. But first, let’s step back and look at our own body, which is actually a collection of

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