Preparations of URS

Dear team,
We require new machine which used in production than my question is who prepared URS Engineering or user production??

Writing a URS is hardly ever a one-person job. Usually all parties are involved.
The user must specify requirements for production while engineering usually have their own set of technical requirements. Also, involve IT if the machine needs a network connection or generates data. And QA, to assign which requirements are GMP related.

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It’s a multiple departmental activities rather than individual work.


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