21 CFR part 11 - section 11.100 - Electronic Signature Certification

[atourni4]

Dear all,

I'm currently implementing the requirements from 21 CFR part 11 in my company and I came across section 11.100 and the following excerpt:
"(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."

My question is quite simple : can anyone here confirm to me that this address is still valid or else provide me with the updated address? Because I searched all over the internet and FDA's website and I couldn't find this address or any alternative one.

Thank you all in advance !

 

[Ajit Basrur]

Dear all,

I'm currently implementing the requirements from 21 CFR part 11 in my company and I came across section 11.100 and the following excerpt:
"(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."

My question is quite simple : can anyone here confirm to me that this address is still valid or else provide me with the updated address? Because I searched all over the internet and FDA's website and I couldn't find this address or any alternative one.

Thank you all in advance !

Yes that is the most current address. Refer 21 CFR 11.100 - General requirements.

You may have missed on FDA's website as the mentioned address belongs to Health Resources & Services Administration (HRSA) which is the headquarters of Office of Regional Operations (ORO)

 

[atourni4]

Thanks a lot for your answer (and apologize for the silly question) !

Best Regards.

 

[Ajit Basrur]

Thanks a lot for your answer (and apologize for the silly question) !

Best Regards.

Remember that there are no silly questions

 

[Bert Peeters]

Hi, I am dealing with a company based in Europe that is using e-signatures for different computerized systems. When I tell them they need to send an attestation to the FDA they state that this is not needed since electronic signatures are legally binding as per their country law. I'm not sure if this is a valid waiver for not sending the attestation to the FDA. Many thanks for your help.

 

[Tidge]

Hi, I am dealing with a company based in Europe that is using e-signatures for different computerized systems. When I tell them they need to send an attestation to the FDA they state that this is not needed since electronic signatures are legally binding as per their country law. I'm not sure if this is a valid waiver for not sending the attestation to the FDA. Many thanks for your help.

There is nothing onerous about providing such an attestation; perhaps you can point out that such a blanket refusal may be indicative of an attitude towards confrontation that is unnecessary and potentially unhelpful?

 

[Ajit Basrur]

Hi, I am dealing with a company based in Europe that is using e-signatures for different computerized systems. When I tell them they need to send an attestation to the FDA they state that this is not needed since electronic signatures are legally binding as per their country law. I'm not sure if this is a valid waiver for not sending the attestation to the FDA. Many thanks for your help.

Your European supplier will need this attestation only if they are impacted by FDA regulations.