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.
3 Likes
It’s a multiple departmental activities rather than individual work.
What about the approval part. Who is the rightful party to approve the URS ? QA or system/equipment owner ?
1 Like
Yes, need to approval from both