Hi,
if the medical device manufacturer who sels products to US, whants to go on electronic system, what it needs to do: register this by FDA and then FDA performs inspection with the scope for Part 11?
Where are those rules defined (for registration and inspection for this scope)?
Thank you.
21 CFR part 11 only describes the expectations/requirements around the use of electronic signatures and electronic records, in place of signatures/records kept on paper. The records/signatures themselves will be required by some other part of the Code, e.g. part 820 for medical device manufacturers. Part 11 is a slightly different animal than other parts of the Code: it doesn't introduce 'new' regulatory requirements; it calls out the minimum necessary implementations that signature/record keeping systems will need (if those signatures records) support other parts of the Code or involve records that are to be submitted to the agency q.v. 11.1(b).
It is important to note that just because some work may done "electronically" it does not mean that the requirements of part 11 automatically apply.
Aside from the formal notice (see
@Candi1024 message above), there is no possible agency inspection specific to "Part 11". If an electronic system implements electronic signatures/records at a manufacturer (again, for the reasons identified above), the manufacturer is expected to be able to demonstrate that the specific electronic system is compliant with part 11 (typically done as part of a computerized system validation/CSV) and that the quality management system (QMS) of the manufacturer supports part 11 (e.g. formally notifying users of the meaning of an electronic signature).
The general QMS pieces are typically done at the time of employee on-boarding, with extra training as associates are given access to new (to them) systems.
The CSV pieces are done system by system; most manufacturers have a formal recognition (for each system) what sort of signatures/records are kept/generated by the (specific) system as well as some assessment/evaluation of the specific requirements the system fulfills with some evidence that the requirements are satisfied.
