Regulatory Open Forum

Anyone has experience with adding LDE user  to the GUDID account? According to the GUDID User Manual the GUDID Coordinator is allowed to Create New Account for LDE user. Once the LDE account is created by the Coordinator a username and temporary password will be sent to the LDE user. Does anyone know how long does it take for the email to be generated? Can the LDE and Coordinator be the same person (same email address) for both roles? We have created the LDE account but no email has been generated/received from the system. Your input is appreciated!

------------------------------
Azita Hedayati
Horiba Medical
Irvine CA
United States
------------------------------

Hi Azita.

I don't specifically work in the device world at this time so I am not completely familiar with timing of these sorts of requests through FDA's system for devices.  However, if the email is automatically generated from the server at FDA to provide a username and temporary password to your LDE I have 2 thoughts:

First, check the spam or junk or whatever folder in your email system that questionable emails might be routed through.  Since this is a server-generated message, it is very possible that it will get caught up as spam even though the email is actually coming via FDA approved software.  I have found many times in dealing with agencies where the initial email is computer-generated directly that the email goes to spam until you clear the sender as an approved email address.  Even then, I routinely check my spam folders just to be sure I haven't missed something because the system email ID changed somehow.

As for your question on the email address to be associated, again, while I am not in the device world, as a general rule, FDA seems to be very much against this sort of duplication of usernames associated with the same email.  The reason is simple - if multiple usernames are associated with a single email address it makes it very difficult for FDA to drill to the bottom of any potential issues.  That could be either regulatory issue or even something as simple as a system issue that you contact FDA to help resolve.  So as a general rule, I would suggest not using the same email address for multiple usernames as this could also create you problem - FDA already has that email address on record as the coordinator and there is no reason to issue a second username and password "to the same person/entity".  As I suspect the coordinator role in FDA's scheme has greater access rights than the LDE role does FDA could reasonably invoke the standard that the user at that email address already has LDE-level rights as the coordinator so the user does not need a separate LDE account as well.

I hope some of this makes sense and is helpful and I am more than certain that someone in the group will let you know if I have not answered according to the CDRH requirements!

------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 05-04-2016 14:57
From: Azita Hedayati
Subject: UDI : LDE User

Anyone has experience with adding LDE user  to the GUDID account? According to the GUDID User Manual the GUDID Coordinator is allowed to Create New Account for LDE user. Once the LDE account is created by the Coordinator a username and temporary password will be sent to the LDE user. Does anyone know how long does it take for the email to be generated? Can the LDE and Coordinator be the same person (same email address) for both roles? We have created the LDE account but no email has been generated/received from the system. Your input is appreciated!

------------------------------
Azita Hedayati
Horiba Medical
Irvine CA
United States
------------------------------

 The issue was related to using the same email address and possibly user name. We assigned a different User Name and email address and was able to create a new LDE account and generate the email notification. Your input was very helpful. Thanks Victor!
 
 
 

------------------------------
Azita Hedayati
Horiba Medical
Irvine CA
United States

Original Message:
Sent: 05-05-2016 08:12
From: Victor Mencarelli
Subject: UDI : LDE User

Hi Azita.

I don't specifically work in the device world at this time so I am not completely familiar with timing of these sorts of requests through FDA's system for devices.  However, if the email is automatically generated from the server at FDA to provide a username and temporary password to your LDE I have 2 thoughts:

First, check the spam or junk or whatever folder in your email system that questionable emails might be routed through.  Since this is a server-generated message, it is very possible that it will get caught up as spam even though the email is actually coming via FDA approved software.  I have found many times in dealing with agencies where the initial email is computer-generated directly that the email goes to spam until you clear the sender as an approved email address.  Even then, I routinely check my spam folders just to be sure I haven't missed something because the system email ID changed somehow.

As for your question on the email address to be associated, again, while I am not in the device world, as a general rule, FDA seems to be very much against this sort of duplication of usernames associated with the same email.  The reason is simple - if multiple usernames are associated with a single email address it makes it very difficult for FDA to drill to the bottom of any potential issues.  That could be either regulatory issue or even something as simple as a system issue that you contact FDA to help resolve.  So as a general rule, I would suggest not using the same email address for multiple usernames as this could also create you problem - FDA already has that email address on record as the coordinator and there is no reason to issue a second username and password "to the same person/entity".  As I suspect the coordinator role in FDA's scheme has greater access rights than the LDE role does FDA could reasonably invoke the standard that the user at that email address already has LDE-level rights as the coordinator so the user does not need a separate LDE account as well.

I hope some of this makes sense and is helpful and I am more than certain that someone in the group will let you know if I have not answered according to the CDRH requirements!

------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
Hain Celestial Group
United States

>>Does anyone know how long does it take for the email to be generated? 

Adding LDE user is very easy and quick.The email comes with in a few minutes after you add a person as LDE. Please check your email spam filters or repeat the process one more time.

>>Can the LDE and Coordinator be the same person (same email address) for both roles? 

GUDID coordinator cannot do data entry. Even if you are the GUDID coordinator, you need to create yourself a role as LDE. You can use the same email id for both roles. 

------------------------------
Prema Chandra RAC
Senior Regulatory Compliance Specialist
NxStage Medical, Inc.
Lawrence MA
United States

Original Message:
Sent: 04-May-2016 14:57
From: Azita Hedayati
Subject: UDI : LDE User

Anyone has experience with adding LDE user  to the GUDID account? According to the GUDID User Manual the GUDID Coordinator is allowed to Create New Account for LDE user. Once the LDE account is created by the Coordinator a username and temporary password will be sent to the LDE user. Does anyone know how long does it take for the email to be generated? Can the LDE and Coordinator be the same person (same email address) for both roles? We have created the LDE account but no email has been generated/received from the system. Your input is appreciated!

------------------------------
Azita Hedayati
Horiba Medical
Irvine CA
United States
------------------------------