Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Does anyone have experience using Veeva as a system for building their regulatory submissions and/or archiving submissions/correspondences? If you do, what is your overall feedback and experience? Thanks in advance for sharing!

​We switched to Veeva as our EDMS this year. Personally, overall I like it better than our previous system. It's much faster and it's much easier to work with the documents and to link to the documents than our previous system. It an be difficult to find documents if the attributes aren't set up well, which is particularly an issue for us for the documents that were migrated from the old system since that wasn't necessarily done well in the old system. This has been an issue for us with our regulatory documents; I work in CMC and our quality documents, which includes our Module 2.3 & 3 documents, are much better, probably because we really spent a lot of time making sure we set it up well and mapped the old system to the new one. I also don't understand how the search function works because I've searched for docs that I know are there but they won't show up in the results.

I'm not responsible for publishing the submissions, so I can't comment on that aspect.

Did you have any specific questions?

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 24-Oct-2018 14:28
From: Anonymous Member
Subject: Veeva Regulatory Submissions/Archive

This message was posted by a user wishing to remain anonymous

Does anyone have experience using Veeva as a system for building their regulatory submissions and/or archiving submissions/correspondences? If you do, what is your overall feedback and experience? Thanks in advance for sharing!

Hi Rachel,

Thank you so much for your helpful insights!

I am also interested in the topic. Would you be so kind as to explain what it did meant for you in your response to "making sure we set it up well and mapped the old system to the new one.", i.e What sort of actions for instance have you undertaken to facilitate this transitioning? Did you conduct for instance a QC check for all your product dossier components to verify they had the correct dossier attributes (can you give some concrete examples) and corrected them? 

Best regards,
Fatima


------------------------------
Fatima Boutimah-Wagenaar
Project Manager RA CMC
Naarden
Netherlands
------------------------------

Original Message:
Sent: 25-Oct-2018 04:55
From: Rachel Thornton
Subject: Veeva Regulatory Submissions/Archive

​We switched to Veeva as our EDMS this year. Personally, overall I like it better than our previous system. It's much faster and it's much easier to work with the documents and to link to the documents than our previous system. It an be difficult to find documents if the attributes aren't set up well, which is particularly an issue for us for the documents that were migrated from the old system since that wasn't necessarily done well in the old system. This has been an issue for us with our regulatory documents; I work in CMC and our quality documents, which includes our Module 2.3 & 3 documents, are much better, probably because we really spent a lot of time making sure we set it up well and mapped the old system to the new one. I also don't understand how the search function works because I've searched for docs that I know are there but they won't show up in the results.

I'm not responsible for publishing the submissions, so I can't comment on that aspect.

Did you have any specific questions?

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States

Original Message:
Sent: 24-Oct-2018 14:28
From: Anonymous Member
Subject: Veeva Regulatory Submissions/Archive

This message was posted by a user wishing to remain anonymous

Does anyone have experience using Veeva as a system for building their regulatory submissions and/or archiving submissions/correspondences? If you do, what is your overall feedback and experience? Thanks in advance for sharing!

Veeva's Vaults have extensive metadata available to you. As Rachel said, the more metadata you set up correctly ahead of time (drug product, API name, active ingredients, inactive ingredients, manufacturers, etc.) the more effective searching and organization is. This actually becomes essential if you use Submissions Archive, as those final sequences need to map correctly to the CMC metadata you have set up. 

Hope this helps some,
 - David


------------------------------
David Knauss
Waltham, MA
United States
------------------------------

Original Message:
Sent: 25-Oct-2018 08:23
From: Fatima Wagenaar
Subject: Veeva Regulatory Submissions/Archive

Hi Rachel,

Thank you so much for your helpful insights!

I am also interested in the topic. Would you be so kind as to explain what it did meant for you in your response to "making sure we set it up well and mapped the old system to the new one.", i.e What sort of actions for instance have you undertaken to facilitate this transitioning? Did you conduct for instance a QC check for all your product dossier components to verify they had the correct dossier attributes (can you give some concrete examples) and corrected them?

Best regards,
Fatima


------------------------------
Fatima Boutimah-Wagenaar
Project Manager RA CMC
Naarden
Netherlands

Original Message:
Sent: 25-Oct-2018 04:55
From: Rachel Thornton
Subject: Veeva Regulatory Submissions/Archive

​We switched to Veeva as our EDMS this year. Personally, overall I like it better than our previous system. It's much faster and it's much easier to work with the documents and to link to the documents than our previous system. It an be difficult to find documents if the attributes aren't set up well, which is particularly an issue for us for the documents that were migrated from the old system since that wasn't necessarily done well in the old system. This has been an issue for us with our regulatory documents; I work in CMC and our quality documents, which includes our Module 2.3 & 3 documents, are much better, probably because we really spent a lot of time making sure we set it up well and mapped the old system to the new one. I also don't understand how the search function works because I've searched for docs that I know are there but they won't show up in the results.

I'm not responsible for publishing the submissions, so I can't comment on that aspect.

Did you have any specific questions?

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States

Original Message:
Sent: 24-Oct-2018 14:28
From: Anonymous Member
Subject: Veeva Regulatory Submissions/Archive

This message was posted by a user wishing to remain anonymous

Does anyone have experience using Veeva as a system for building their regulatory submissions and/or archiving submissions/correspondences? If you do, what is your overall feedback and experience? Thanks in advance for sharing!

This message was posted by a user wishing to remain anonymous

Rachel, thank you for sharing your recent experience with Veeva! My question was about your experience in general although it would be helpful to learn whether you're using the Submissions module to author documents - does it work well with multiple team members, have you had any issues with versioning of a document during the authoring process?  I believe the archive comes with a basic eCTD viewer.  Does it work well?  Can you see current and cumulative view?  My other concern (which you already touched on) is searching for documents, especially by people who didn't place the documents in the system and may be less familiar with the structure.  Thanks again!
Original Message:
Sent: 25-Oct-2018 04:55
From: Rachel Thornton
Subject: Veeva Regulatory Submissions/Archive

​We switched to Veeva as our EDMS this year. Personally, overall I like it better than our previous system. It's much faster and it's much easier to work with the documents and to link to the documents than our previous system. It an be difficult to find documents if the attributes aren't set up well, which is particularly an issue for us for the documents that were migrated from the old system since that wasn't necessarily done well in the old system. This has been an issue for us with our regulatory documents; I work in CMC and our quality documents, which includes our Module 2.3 & 3 documents, are much better, probably because we really spent a lot of time making sure we set it up well and mapped the old system to the new one. I also don't understand how the search function works because I've searched for docs that I know are there but they won't show up in the results.

I'm not responsible for publishing the submissions, so I can't comment on that aspect.

Did you have any specific questions?

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States

Original Message:
Sent: 24-Oct-2018 14:28
From: Anonymous Member
Subject: Veeva Regulatory Submissions/Archive

This message was posted by a user wishing to remain anonymous

Does anyone have experience using Veeva as a system for building their regulatory submissions and/or archiving submissions/correspondences? If you do, what is your overall feedback and experience? Thanks in advance for sharing!

This message was posted by a user wishing to remain anonymous

I have been involved with some early discussions with assessing Veeva's offerings for our organization and had few related questions.

How does the Registrations module fit into the picture? Is it only useful for post-approval marketed products? Or can a smaller organization leverage it for early to mid stage global clinical development activities?

I haven't been able to wrap my head around Registrations since early talks and demos with Veeva and the overview and videos available on their website have not been particularly helpful in determining how useful it might be.
Original Message:
Sent: 25-Oct-2018 09:26
From: Anonymous Member
Subject: Veeva Regulatory Submissions/Archive

This message was posted by a user wishing to remain anonymous

Rachel, thank you for sharing your recent experience with Veeva! My question was about your experience in general although it would be helpful to learn whether you're using the Submissions module to author documents - does it work well with multiple team members, have you had any issues with versioning of a document during the authoring process?  I believe the archive comes with a basic eCTD viewer.  Does it work well?  Can you see current and cumulative view?  My other concern (which you already touched on) is searching for documents, especially by people who didn't place the documents in the system and may be less familiar with the structure.  Thanks again!
Original Message:
Sent: 25-Oct-2018 04:55
From: Rachel Thornton
Subject: Veeva Regulatory Submissions/Archive

​We switched to Veeva as our EDMS this year. Personally, overall I like it better than our previous system. It's much faster and it's much easier to work with the documents and to link to the documents than our previous system. It an be difficult to find documents if the attributes aren't set up well, which is particularly an issue for us for the documents that were migrated from the old system since that wasn't necessarily done well in the old system. This has been an issue for us with our regulatory documents; I work in CMC and our quality documents, which includes our Module 2.3 & 3 documents, are much better, probably because we really spent a lot of time making sure we set it up well and mapped the old system to the new one. I also don't understand how the search function works because I've searched for docs that I know are there but they won't show up in the results.

I'm not responsible for publishing the submissions, so I can't comment on that aspect.

Did you have any specific questions?

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States

Original Message:
Sent: 24-Oct-2018 14:28
From: Anonymous Member
Subject: Veeva Regulatory Submissions/Archive

This message was posted by a user wishing to remain anonymous

Does anyone have experience using Veeva as a system for building their regulatory submissions and/or archiving submissions/correspondences? If you do, what is your overall feedback and experience? Thanks in advance for sharing!

This message was posted by a user wishing to remain anonymous

As with any document management system (DMS), you should have one person responsible for setting it up and maintaining the structure. If you have people who do not understand the principles behind the filing system/structure, does not understand the submission process, or doesn't possess basic logic, you might (almost certain) end up with a mess on your hands. I know this from experience, unfortunately.

The other key "ingredient" to a successful DMS is using the metadata fields religiously, for every single document. Your DMS gatekeeper should not allow any documents to be put into the system with out the agreed upon minimum fields completed. That is unless you want your search to return hundreds of documents, all except the one you need.

Setting up your DMS takes thought, planning, execution, follow-up, backup and lock down (when necessary). Your DMS gatekeeper should enlist help from your RA/QA folks to ensure that all documents are placed appropriately and test the system to ensure that your key words actually work when searching for documents. 

One last thing (in my humble opinion) your gatekeeper should focus solely on the management and upkeep of your DMS if you want this tool to actually pay for itself. Remember the saying "garbage in / garbage out"? 

As for the Veeva DMS, I don't have any personal experience with using this software. However, I did like how it functioned and contained most of the items on my wish list. Maybe you could see about a trial or try before you buy and test it out yourself? Might be worth looking into.
Original Message:
Sent: 24-Oct-2018 14:28
From: Anonymous Member
Subject: Veeva Regulatory Submissions/Archive

This message was posted by a user wishing to remain anonymous

Does anyone have experience using Veeva as a system for building their regulatory submissions and/or archiving submissions/correspondences? If you do, what is your overall feedback and experience? Thanks in advance for sharing!

This message was posted by a user wishing to remain anonymous

We're in the process of procuring an Doc Mgmt System also. Veeva is actually incredibly expensive and lacks good customer support. I did not have a good experience interacting with them and they are extremely sales-heavy. Before you know it, you will have multiple modules of Veeva since it does not integrate well with other systems. There are much cheaper and equally comparable options out there. In my case, cost was not a deciding factor. I would encourage you to explore more.
Original Message:
Sent: 24-Oct-2018 14:28
From: Anonymous Member
Subject: Veeva Regulatory Submissions/Archive

This message was posted by a user wishing to remain anonymous

Does anyone have experience using Veeva as a system for building their regulatory submissions and/or archiving submissions/correspondences? If you do, what is your overall feedback and experience? Thanks in advance for sharing!