Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

My company (size 35) is planning to transition to eIFUs. We are familiar with the benefits and regulatory requirements. We don't have a dedicated in-house IT team, we work with an external vendor who manages our website. We are struggling to understand what documents are needed to support V&V for eIFU which will be used in the regulatory submissions to our NB. 

1. We plan to start with an eIFU risk assessment, which will feed into our requirement documents.
2. Based on the requirements document, we will have a process on how do we plan to manage the eIFUs (Management procedure).
3. We are asking our website vendor to provide procedures on their IT firewall monitoring, maintenance and operations and the IT management process for back-up and restoration in case of a unplanned website failure. 
4. We are asking our website developer to provide test reports showing how they validated that the eIFU can be accessed on different browsers and on different platforms (tablets, laptops, phone). 
5. Along with our website developers, we will develop a procedure to define who has authorization for posting the eIFUs to the website.

Is there anything else we need to ensure we have necessary testing/documents/procedure before we can use them for our regulatory submission to our NB for their approval? Any insight will help us to transition to eIFUs. 

Hello Anon,

Information you are asking about can be quite extensive, probably more than a simple post on a forum.  However, the information you have included in your list seems to be approach.  Without knowing product types, IFU content, and how you are managing internally as a company, would be difficult to provide further information.  There is quite some disparity in the European Union for eIFUs so definitely use caution as this is not well understood, nor totally accepted.  I personally would not seek "approval" from the NB as this would be processes implemented in your quality management system as you indicate.  Again the approach seems reasonable, as with any QMS system make sure you document what you are doing and if there are questions, provide rationale for any approach you are making.

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

Original Message:
Sent: 20-Aug-2021 12:12
From: Anonymous Member
Subject: eIFU Verification and Validation

This message was posted by a user wishing to remain anonymous

My company (size 35) is planning to transition to eIFUs. We are familiar with the benefits and regulatory requirements. We don't have a dedicated in-house IT team, we work with an external vendor who manages our website. We are struggling to understand what documents are needed to support V&V for eIFU which will be used in the regulatory submissions to our NB.

1. We plan to start with an eIFU risk assessment, which will feed into our requirement documents.
2. Based on the requirements document, we will have a process on how do we plan to manage the eIFUs (Management procedure).
3. We are asking our website vendor to provide procedures on their IT firewall monitoring, maintenance and operations and the IT management process for back-up and restoration in case of a unplanned website failure. 
4. We are asking our website developer to provide test reports showing how they validated that the eIFU can be accessed on different browsers and on different platforms (tablets, laptops, phone). 
5. Along with our website developers, we will develop a procedure to define who has authorization for posting the eIFUs to the website.

Is there anything else we need to ensure we have necessary testing/documents/procedure before we can use them for our regulatory submission to our NB for their approval? Any insight will help us to transition to eIFUs.

Hello Anonymous,
You correctly recognize that the implementation of an eIFU solution has to be carefully planned and a process outlined. I have written articles on the importance of applying design control principles,  including risk management, verification and validation, of identifying the impact on different QMS processes and on Notified Body expectations.
Notified Bodies do pay attention to eIFU solutions and at least some have checklists, used by their auditors, to check compliance with the (European) regulatory requirements and a correct integration in the QMS. I would like to point out that the implementation of an eIFU solution represents a significant change of the QMS and therefore has to be submitted to a Notified Body as such. 
My company has 12 years of experience in the development and commercialization of an eIFU platform.  We are also a consulting company in QA and RA since 21 years. This results in a full understanding of the regulatory and practical requirements of an eIFU solution. We built the solutions and answers into our web platform and into its supporting documentation. Our customers do not have to teach regulations to their web developer. We actually teach and support our customers. 
I am afraid that this looks a bit like an advertisement, but it could also lead to an efficient solution for your company and to less headaches for those involved. Feel free to contact me for copies of the articles that I referred to.

------------------------------
Dirk Stynen PhD
President
Belgium
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu
------------------------------

Original Message:
Sent: 23-Aug-2021 05:43
From: Richard Vincins
Subject: eIFU Verification and Validation

Hello Anon,

Information you are asking about can be quite extensive, probably more than a simple post on a forum.  However, the information you have included in your list seems to be approach.  Without knowing product types, IFU content, and how you are managing internally as a company, would be difficult to provide further information.  There is quite some disparity in the European Union for eIFUs so definitely use caution as this is not well understood, nor totally accepted.  I personally would not seek "approval" from the NB as this would be processes implemented in your quality management system as you indicate.  Again the approach seems reasonable, as with any QMS system make sure you document what you are doing and if there are questions, provide rationale for any approach you are making.

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

Original Message:
Sent: 20-Aug-2021 12:12
From: Anonymous Member
Subject: eIFU Verification and Validation

This message was posted by a user wishing to remain anonymous

My company (size 35) is planning to transition to eIFUs. We are familiar with the benefits and regulatory requirements. We don't have a dedicated in-house IT team, we work with an external vendor who manages our website. We are struggling to understand what documents are needed to support V&V for eIFU which will be used in the regulatory submissions to our NB.

1. We plan to start with an eIFU risk assessment, which will feed into our requirement documents.
2. Based on the requirements document, we will have a process on how do we plan to manage the eIFUs (Management procedure).
3. We are asking our website vendor to provide procedures on their IT firewall monitoring, maintenance and operations and the IT management process for back-up and restoration in case of a unplanned website failure. 
4. We are asking our website developer to provide test reports showing how they validated that the eIFU can be accessed on different browsers and on different platforms (tablets, laptops, phone). 
5. Along with our website developers, we will develop a procedure to define who has authorization for posting the eIFUs to the website.

Is there anything else we need to ensure we have necessary testing/documents/procedure before we can use them for our regulatory submission to our NB for their approval? Any insight will help us to transition to eIFUs.

This message was posted by a user wishing to remain anonymous

Hello Dirk,
Thank you for the information. I agree, we spoke to our NB and they have asked us to submit a supplement since moving to eIFU is a significant change in our quality system. 

Could you share the copies of the articles (specially around V&V activities for eIFUs) which you mentioned about above in your message.
Thanks
SS
Original Message:
Sent: 23-Aug-2021 09:54
From: Dirk Stynen
Subject: eIFU Verification and Validation

Hello Anonymous,
You correctly recognize that the implementation of an eIFU solution has to be carefully planned and a process outlined. I have written articles on the importance of applying design control principles,  including risk management, verification and validation, of identifying the impact on different QMS processes and on Notified Body expectations.
Notified Bodies do pay attention to eIFU solutions and at least some have checklists, used by their auditors, to check compliance with the (European) regulatory requirements and a correct integration in the QMS. I would like to point out that the implementation of an eIFU solution represents a significant change of the QMS and therefore has to be submitted to a Notified Body as such.
My company has 12 years of experience in the development and commercialization of an eIFU platform.  We are also a consulting company in QA and RA since 21 years. This results in a full understanding of the regulatory and practical requirements of an eIFU solution. We built the solutions and answers into our web platform and into its supporting documentation. Our customers do not have to teach regulations to their web developer. We actually teach and support our customers.
I am afraid that this looks a bit like an advertisement, but it could also lead to an efficient solution for your company and to less headaches for those involved. Feel free to contact me for copies of the articles that I referred to.

------------------------------
Dirk Stynen PhD
President
Belgium
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu

Original Message:
Sent: 23-Aug-2021 05:43
From: Richard Vincins
Subject: eIFU Verification and Validation

Hello Anon,

Information you are asking about can be quite extensive, probably more than a simple post on a forum.  However, the information you have included in your list seems to be approach.  Without knowing product types, IFU content, and how you are managing internally as a company, would be difficult to provide further information.  There is quite some disparity in the European Union for eIFUs so definitely use caution as this is not well understood, nor totally accepted.  I personally would not seek "approval" from the NB as this would be processes implemented in your quality management system as you indicate.  Again the approach seems reasonable, as with any QMS system make sure you document what you are doing and if there are questions, provide rationale for any approach you are making.

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

Original Message:
Sent: 20-Aug-2021 12:12
From: Anonymous Member
Subject: eIFU Verification and Validation

This message was posted by a user wishing to remain anonymous

My company (size 35) is planning to transition to eIFUs. We are familiar with the benefits and regulatory requirements. We don't have a dedicated in-house IT team, we work with an external vendor who manages our website. We are struggling to understand what documents are needed to support V&V for eIFU which will be used in the regulatory submissions to our NB.

1. We plan to start with an eIFU risk assessment, which will feed into our requirement documents.
2. Based on the requirements document, we will have a process on how do we plan to manage the eIFUs (Management procedure).
3. We are asking our website vendor to provide procedures on their IT firewall monitoring, maintenance and operations and the IT management process for back-up and restoration in case of a unplanned website failure. 
4. We are asking our website developer to provide test reports showing how they validated that the eIFU can be accessed on different browsers and on different platforms (tablets, laptops, phone). 
5. Along with our website developers, we will develop a procedure to define who has authorization for posting the eIFUs to the website.

Is there anything else we need to ensure we have necessary testing/documents/procedure before we can use them for our regulatory submission to our NB for their approval? Any insight will help us to transition to eIFUs.

Hi,

You find the articles on https://www.qarad.com/blogs. There are articles on other topics as well, but I believe that the titles are clear enough.
These articles are not going into detail. We have complete sets of verification and validation protocols and reports, but I suggest you contact me directly for that kind of information. 
Best regards, 
Dirk

------------------------------
Dirk Stynen PhD
President
Belgium
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu
------------------------------

Original Message:
Sent: 23-Aug-2021 12:40
From: Anonymous Member
Subject: eIFU Verification and Validation

This message was posted by a user wishing to remain anonymous

Hello Dirk,
Thank you for the information. I agree, we spoke to our NB and they have asked us to submit a supplement since moving to eIFU is a significant change in our quality system.

Could you share the copies of the articles (specially around V&V activities for eIFUs) which you mentioned about above in your message.
Thanks
SS
Original Message:
Sent: 23-Aug-2021 09:54
From: Dirk Stynen
Subject: eIFU Verification and Validation

Hello Anonymous,
You correctly recognize that the implementation of an eIFU solution has to be carefully planned and a process outlined. I have written articles on the importance of applying design control principles,  including risk management, verification and validation, of identifying the impact on different QMS processes and on Notified Body expectations.
Notified Bodies do pay attention to eIFU solutions and at least some have checklists, used by their auditors, to check compliance with the (European) regulatory requirements and a correct integration in the QMS. I would like to point out that the implementation of an eIFU solution represents a significant change of the QMS and therefore has to be submitted to a Notified Body as such.
My company has 12 years of experience in the development and commercialization of an eIFU platform.  We are also a consulting company in QA and RA since 21 years. This results in a full understanding of the regulatory and practical requirements of an eIFU solution. We built the solutions and answers into our web platform and into its supporting documentation. Our customers do not have to teach regulations to their web developer. We actually teach and support our customers.
I am afraid that this looks a bit like an advertisement, but it could also lead to an efficient solution for your company and to less headaches for those involved. Feel free to contact me for copies of the articles that I referred to.

------------------------------
Dirk Stynen PhD
President
Belgium
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu

Original Message:
Sent: 23-Aug-2021 05:43
From: Richard Vincins
Subject: eIFU Verification and Validation

Hello Anon,

Information you are asking about can be quite extensive, probably more than a simple post on a forum.  However, the information you have included in your list seems to be approach.  Without knowing product types, IFU content, and how you are managing internally as a company, would be difficult to provide further information.  There is quite some disparity in the European Union for eIFUs so definitely use caution as this is not well understood, nor totally accepted.  I personally would not seek "approval" from the NB as this would be processes implemented in your quality management system as you indicate.  Again the approach seems reasonable, as with any QMS system make sure you document what you are doing and if there are questions, provide rationale for any approach you are making.

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

Original Message:
Sent: 20-Aug-2021 12:12
From: Anonymous Member
Subject: eIFU Verification and Validation

This message was posted by a user wishing to remain anonymous

My company (size 35) is planning to transition to eIFUs. We are familiar with the benefits and regulatory requirements. We don't have a dedicated in-house IT team, we work with an external vendor who manages our website. We are struggling to understand what documents are needed to support V&V for eIFU which will be used in the regulatory submissions to our NB.

1. We plan to start with an eIFU risk assessment, which will feed into our requirement documents.
2. Based on the requirements document, we will have a process on how do we plan to manage the eIFUs (Management procedure).
3. We are asking our website vendor to provide procedures on their IT firewall monitoring, maintenance and operations and the IT management process for back-up and restoration in case of a unplanned website failure. 
4. We are asking our website developer to provide test reports showing how they validated that the eIFU can be accessed on different browsers and on different platforms (tablets, laptops, phone). 
5. Along with our website developers, we will develop a procedure to define who has authorization for posting the eIFUs to the website.

Is there anything else we need to ensure we have necessary testing/documents/procedure before we can use them for our regulatory submission to our NB for their approval? Any insight will help us to transition to eIFUs.