Regulatory Open Forum

Hello RAPS Community!

Hope everyone is doing well.  I have a question regarding  the management of Device History Records/ Device History Files as a Distributor. I know that as a Manufacturer, those need to be in place as required by part 21 CFR 820 for the history of the device. 

Background: Our company implemented a ERP system (SAP) as of July 2020 and have been using that to enter POs (invoices), Customer Information, Product Information, Serial Number,  and Tracking Number. Since we are only a distributor, we do not keep the information of the entire history of the device as would a manufacturer.

In the past, we had to print the hard copy off several of our systems and save it in a folder and file it because the system we were using didn't communicate with one another. Now that we implemented a ERP system,  all that info is stored in SAP electronically. 

Question: We wanted to know if there is some FDA regulation requirement as a distributor, to keep an external hard copy (or even a file folder on our computer drive) of the DHR/DHF? We are trying to shy away from paper based records. We wanted to know what the required regulation is for distributors in managing and keeping Device History records.

Any knowledge on this matter is appreciated.

Thank you,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Hello Vicki,

The regulations are not specific whether paper-based or electronic records are maintained, but most regulatory agencies including the US FDA recognise companies keep only electronic records.  There should not be a problem for you to maintain only electronic DHR records, ensure you have a process clearly defined for these activities.  Also note, more of a practical nomenclature the records being kept by distributors are more "distribution records" and not Device History Records.  In the context of US FDA, Device History Records would be the actual manufacturing of the product up until the point the product is released for sale.  Those records being kept in your ERP system are shipping and distribution records; as you said the entire history of the device is with the manufacturer.  You might confuse some calling those distribution records a DHR or DHF as the nomenclature is used differently.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 18-Jun-2021 16:01
From: Vicki Ong
Subject: Device History Records Inquiry

Hello RAPS Community!

Hope everyone is doing well.  I have a question regarding  the management of Device History Records/ Device History Files as a Distributor. I know that as a Manufacturer, those need to be in place as required by part 21 CFR 820 for the history of the device.

Background: Our company implemented a ERP system (SAP) as of July 2020 and have been using that to enter POs (invoices), Customer Information, Product Information, Serial Number,  and Tracking Number. Since we are only a distributor, we do not keep the information of the entire history of the device as would a manufacturer.

In the past, we had to print the hard copy off several of our systems and save it in a folder and file it because the system we were using didn't communicate with one another. Now that we implemented a ERP system,  all that info is stored in SAP electronically.

Question: We wanted to know if there is some FDA regulation requirement as a distributor, to keep an external hard copy (or even a file folder on our computer drive) of the DHR/DHF? We are trying to shy away from paper based records. We wanted to know what the required regulation is for distributors in managing and keeping Device History records.

Any knowledge on this matter is appreciated.

Thank you,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Thanks Richard for your response. Much Appreciated!

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Original Message:
Sent: 19-Jun-2021 07:33
From: Richard Vincins
Subject: Device History Records Inquiry

Hello Vicki,

The regulations are not specific whether paper-based or electronic records are maintained, but most regulatory agencies including the US FDA recognise companies keep only electronic records.  There should not be a problem for you to maintain only electronic DHR records, ensure you have a process clearly defined for these activities.  Also note, more of a practical nomenclature the records being kept by distributors are more "distribution records" and not Device History Records.  In the context of US FDA, Device History Records would be the actual manufacturing of the product up until the point the product is released for sale.  Those records being kept in your ERP system are shipping and distribution records; as you said the entire history of the device is with the manufacturer.  You might confuse some calling those distribution records a DHR or DHF as the nomenclature is used differently.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 18-Jun-2021 16:01
From: Vicki Ong
Subject: Device History Records Inquiry

Hello RAPS Community!

Hope everyone is doing well.  I have a question regarding  the management of Device History Records/ Device History Files as a Distributor. I know that as a Manufacturer, those need to be in place as required by part 21 CFR 820 for the history of the device.

Background: Our company implemented a ERP system (SAP) as of July 2020 and have been using that to enter POs (invoices), Customer Information, Product Information, Serial Number,  and Tracking Number. Since we are only a distributor, we do not keep the information of the entire history of the device as would a manufacturer.

In the past, we had to print the hard copy off several of our systems and save it in a folder and file it because the system we were using didn't communicate with one another. Now that we implemented a ERP system,  all that info is stored in SAP electronically.

Question: We wanted to know if there is some FDA regulation requirement as a distributor, to keep an external hard copy (or even a file folder on our computer drive) of the DHR/DHF? We are trying to shy away from paper based records. We wanted to know what the required regulation is for distributors in managing and keeping Device History records.

Any knowledge on this matter is appreciated.

Thank you,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------