FDA & 21 CFR Part 11

Larix

Registered
#1
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.
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
We self-certified to Part 11 as this is the only method I know of to comply with Part 11.

Here is the Part 11 memo we used.
1625838139649.png
1625838199393.png
I deleted obviously our specific answers and the questions for our company. You also should add your data retention policy here. Your answers will be different than ours but you need to explain in the answer field why it does not apply. Closed vs open systems for example.
 

chris1price

Trusted Information Resource
#4
Hi, I've been out of this subject for some time, but didn't realise there was a requirement to register or certify to Part 11. Can you explain the purpose of this and where I can find the requirement?
 

blackholequasar

Involved In Discussions
#5
From my understanding, 21 CFR Part 11 states that electronic records and electronic signatures are treated the same as paper records and handwritten signatures. Regulated companies with any documents or records in electronic format must comply with the regulation. In my experience with medical device, you have to prove the verity and intention of an electronic signature - the easiest way to do that is to comply with Part 11. If you can prove compliance, you can prove that you electronic signatures are not subject to falsification.
 

chris1price

Trusted Information Resource
#6
Thanks, I thought the OP was suggesting you had to specifically notify FDA that you were following Part 11. I can't see any requirement for this.
 

blackholequasar

Involved In Discussions
#7
Oh! Yeah, we never notified the FDA of anything in regards to Part 11! Sorry about that haha. I don't believe there is a requirement for that at all.
 

Tidge

Trusted Information Resource
#10
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.
 
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