Going Live with FDA GUDID Production Account

[MinhLamAroa]

Hi 1WorldSync Community,

Our organization has completed all the FDA pre-production testing scenarios, and we are in the process of establishing our Production GUDID account with the FDA.

We currently have items in Item Management that we have published to the global registry and shared with trading partners. We also have an independent dataset of our products in the FDA GUDID database. Note that the items currently in the FDA GUDID database have been uploaded manually, and the items are all past the grace period. 

My question is - once we go live with our FDA GUDID Production account, how do I go about uploading new data or modifying existing data within the FDA GUDID database? Would I need to maintain a separate dataset for the GUDID? Is it possible to modify any data that for items that already exist in the GUDID? 

Any help would be appreciated on this matter. 

Thank you!

[Julie]

Hello @MinhLamAroa and thanks for reaching out.

From the Steps to Sync with the FDA via GDSN:

Item maintenance – Important rules exist regarding timelines as to when certain attributes can be maintained. Refer to the FDA Implementation Guide, Section 3.6 for these rules.

Please review the FDA GUDID Implementation Guide as it provides additional information about item updates, you will be interested in section 3.6 Modify/Correct. Thank you!

[MinhLamAroa]

Hi Julie,

Thank you for providing the details for item maintenance and sharing the implementation guide. 

However, my question is how I would go about maintaining the existing data in Item Management (shared with trading partners and registered in the Global Registry) along with my existing data in FDA GUDID (production). We have existing data in the FDA GUDID database, and we wish to move forward with Item Management for any future GTINs added. E.g., we have one GTIN that is currently in 1WorldSync Item Management that is published to trading partners, and then we also have that same GTIN published in GUDID. The data of this GTIN was not published via Item Management, therefore, would there be any issues if we are to modify certain attributes in Item Management and publish it to the GUDID?  

For existing items in FDA GUDID, I assume that I would need to make sure the GTIN is the same in Item Management and GUDID to make sure the synchronization works, and I understand that I would only be able to modify certain attributes. 

For new items, would I create these in Item Management and publish it to the FDA GUDID? And maintain the attribute data within Item Management? Which removes the need of uploading data in GUDID manually? 

Would there be any issues with the methods I have outlined above? 

Thank you!

[Val_P]

Hello @MinhLamAroa and thank you for the follow up!
We are are looking further into this for you and will be providing additional information shortly.
Thank you for your time and patience while researching this.

[Scott_Brown]

MinhLamAroa,

Thanks for the note.

Let's start with the easy one first. To add new items, you would set items up as you do now. Make sure you have all the content populated. You can use the playlists (recipient and FDA GUDID) to validate your content. Once they are ready, you can publish them to all recipients and the GUDID, as necessary.

For updates to items which are in Item Management (IM) and not in the GUDID, you can make updates to them as needed. If you do not need to send them to the GUDID, these changes will be synchronized out to those you have published them to. If you need to add the GUDID as a recipient, first validate the items using the playlist. Then add the GUDID as a recipient.

For those items which have been previously published to the GUDID outside of IM, you will need to work with your implementation manager to get these set up. If they are not in IM at all, you will need to add them. Once added, and for those already in IM, validate the content against the GUDID Playlist. Before you publish these to the GUDID, your implementation manager will need some ids for the items in your Access GUDID account. They will give you instructions on how to retrieve these ids. Once you provide them, they will be loaded. This allows us to send changes to the GUDID using the ids as opposed to creating new ids causing the items to appear as new. Keep in mind that not all fields can be edited/changed once the grace period has ended.