Hello World,
I work in QA at a small biologics manufacturer and have been assigned to lead a 21 CFR Part 11 compliance project. I was told that I would need to create User Requirement Specification documents for our LIMS, QMS, analytical equipment and spreadsheets.
Do I write the URSs per the intended system functionality and/or Part 11 requirements? These are not new systems and I'm confused as to which requirements to list.
Any insight would be greatly appreciated!
Thank you!
I work in QA at a small biologics manufacturer and have been assigned to lead a 21 CFR Part 11 compliance project. I was told that I would need to create User Requirement Specification documents for our LIMS, QMS, analytical equipment and spreadsheets.
Do I write the URSs per the intended system functionality and/or Part 11 requirements? These are not new systems and I'm confused as to which requirements to list.
Any insight would be greatly appreciated!
Thank you!