Compliance to 21 CFR Part 11 Require Registration to FDA?

[dsudduth]

In a past audit, the auditor recommended that if an establishment had implemented electronic signature capability for its quality system, the establishment needed to register with the FDA. We searched the FDA website for this requirement under 21 Part 11 but only found reference to the registration for electronic, e-signed MDR submissions. Any thoughts from this group?

 

[Ajit Basrur]

Are you refering to 21 CFR Part 11.100 (c) -

(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.

(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature

 

[dsudduth]

Yes, 21 CFR Part 11.100(c). Understand, but do you know if the agency is enforcing this requirement?

 

[Ajit Basrur]

Yes, 21 CFR Part 11.100(c). Understand, but do you know if the agency is enforcing this requirement?

Its the law and to be followed.

 

[sagai]

Actually I can not recall any warning letter that was addressed any part11 related deficiencies to be honest.

 

[MIREGMGR]

In a past audit, the auditor recommended that if an establishment had implemented electronic signature capability for its quality system, the establishment needed to register with the FDA.

I'm unclear on what's being asked. An Establishment is a company that engages in one or more of several regulated activity-types pertaining to medical devices, or something else that FDA regulates. You Register to become an Establishment. Whether or not you need to Register has nothing to do with whether you have an electronic signatures/record system. It would be perfectly acceptable for a company that is not required to Register to have an electronic signatures/records system that technically would comply with Part 11. The fact that that company has such a system has no bearing on whether they are required to Register.

Some Establishments use the electronic submissions capability that FDA has set up, for MDRs or certain other filing types. This capability and Part 11 have essentially nothing to do with each other.

Some Establishments use the electronic submission compilation and formatting software that FDA provides. This software also has nothing to do with Part 11.

 

[Ronen E]

I'm unclear on what's being asked. An Establishment is a company that engages in one or more of several regulated activity-types pertaining to medical devices, or something else that FDA regulates. You Register to become an Establishment. Whether or not you need to Register has nothing to do with whether you have an electronic signatures/record system. It would be perfectly acceptable for a company that is not required to Register to have an electronic signatures/records system that technically would comply with Part 11. The fact that that company has such a system has no bearing on whether they are required to Register.

Some Establishments use the electronic submissions capability that FDA has set up, for MDRs or certain other filing types. This capability and Part 11 have essentially nothing to do with each other.

Some Establishments use the electronic submission compilation and formatting software that FDA provides. This software also has nothing to do with Part 11.

Based on the OP's clarification

Yes, 21 CFR Part 11.100(c).

I believe that "registration" was merely a poor choice of word, while they were actually referring to "certification", as described in 21 CFR Part 11.100(c).

 

[sagai]

so how could it be "certify to agency" ?
Cheers!

 

[v9991]

i agree with MIREGMGR....

This is not an approval process, but instead, it is a way to let FDA knows that the electronic signatures in their systems are intended to be the legally binding equivalent of traditional handwritten signatures.

http ://www. fda. gov/ downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM059232.pdf - DEAD LINK

further, here's few references of 483/warning letter citations on ER/ES...

"Processes have not been approved. Electronic records are used, but they do not meet employee accountability/responsibility policy and signature manifestation requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records

"

The document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance. Electronic records are used, but they do not meet signature manifestation requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

Document control procedures were not complete. Electronic records are used, but they do not meet retention requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

Specifically,

Gaps are encountered in the RPR record numbers where sequential auto record numbering is used to create the RPR record numbers.
Work orders are generated and implemented without evidence of electronic signature or other evidence of signature and approval date.

http :// www. fda. gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm061783.htm - DEAD LINK

"

Electronic signatures are being used in the complaint and incoming inspection systems and the firm has yet to certify to FDA that the electronic signatures in their systems are intended to be legally binding equivalent of traditional handwritten signatures.

"
"

e electronic records and signatures, there are no procedures addressing the following:
a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and
the ability to discern invalid or altered records.
b) The ability to generate accurate and complete copies of records.
c) Protection of records throughout the record retention period.
d) Limiting system access.
e) And the system can create an audit trail that is computer-generated, time stamped to
independently record the date and time of operator entries and actions.

"
http: // www. fda. gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM059232.pdf - DEAD LINK

 

[Mark Meer]

so how could it be "certify to agency" ?

This thread talks more about the certification.

Basically, it's just a signed statement. The recommended wording (see FR vol. 62, no. 54, page 13456 (comment 120)) is:

"Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that [name of organization] intends that all electronic signatures executed by our employees, agents, or representatives, located anywhere in the world, are the legally binding equivalent of traditional handwritten signatures."

Sign it and send it to the address given in 21 CFR 11.100.
There is no need to wait for a reply.
As far as I know, that is all that is involved.