Is it Mandatory to have 21 CFR Part 11 Assessment Report for Every Computerized System?

COMPUTER SYSTEM VALIDATION (CSV)
1

Kindly let us know is it mandatory to have 21 CFR part 11 assessment report for each and every computerized systems?

During the user requirements specification , if the specification is covering all the specifications regarding part 11, those can be traced out as part of tractability matrix, then in this case can we require separate part 11 assessment?

2

No. For example the accounting department can have software that is not 21 CFR part 11 compliant (in that case who cares!). This regulation is only for departments that make decisions on the quality of the drug product. An example is purchasing since they can order the spoons in the cafeteria or the API.