The FDA Food Safety Modernization Act (FSMA) aims to reform the food safety approach of industries in the United States. The rule addresses different concerns of each sector in the food industry with a goal to minimize the potential impacts of foodb...
Hi 1WS Community,I have successfully synchronized our item information with the FDA GUDID. Most attributes have been synchronized and it looks great, however, there are a few attributes that I am struggling with as it doesn't appear in the GUDID.The ...
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...
Dear support desk, I found out that my error connected the issue. In 1worldsync database, Item showed up by the H: Item name, but FDA, GUDID showed up CE: Alternate Item Identification ID. I made typo in CE: Alternate Item Identification ID, and that...
I uploaded the data in Pre-prod, and got data synchronized, so uploaded to the Prod. However the data stayed "Received" status, and not synchronized for a week now. What should I do now?
The 1WorldSync Training team created the FDA Quick Sheets to help you quickly get started with a basic overview of the steps you will take to successfully synchronize your product content with the FDA. It would also help you to review the FDA Imple...
Hello. I successfully published to GUDID, but noticed that I missed a field (the Y/N question in GUDID for “Manufacturing Date”). I went back to the FUSE worksheet, added a new “APPEND” row, entered "PRODUCTION_DATE" under the packagingDate/tradeItem...
I'm currently updating a large number of records. When I look at the records, all of them show a First Ship Date/Time as today. There is also not a UDID First Publication Date in the Medical Device information tab. Is there an issue with the dates...
I have several items that are being obsoleted, so I need to update in GUDID. Unfortunately, 1WS has the wrong publish date listed, so is giving me an error. How can I change the publish date for these items to match what is in GUDID?
Items in 1worldsync site do not match the gudid site names, so gudid site showing/not showing correct information. Is there a way define fda's descriptions to 1worlds'?
I have a few items that accessgudid site is not listing: My fda product code, dm data was corrected, and production identifiers (in udi) cannot findl expiration date indicator. items in printed form do not match the input site.
Where in the app do i put my 3rd party (1world) No matter where I put the info I get the c999 error.
Hello, We have submitted MODIFY and new product publication commands to the GUDID and all items seem to be stuck in the "received" state since Monday. Can someone please check server connections to the FDA?
I have imported approximately 200 records and published to the FDA (GUDID). The records were received, but never synchronized. Do I need to publish again? I published them on Friday morning - still not synced as of Monday morning.
Please see the attached guide
I have called 860-280-4013 and emailed technicalsupport@1worldsync.com. I am not receiving a response from either. Please have someone call me at 325-773-3918 asap.
Please provide guidance on how to transform all our data to FDA UDI. Please provide the additional attributes that we need to add. Please have a side-by-side comparison of the attributes of customer publication versus US FDA. Is there a FUSE template...
I have been trying to submit records to the FDA for over a week and they d not go through. I only receive the first acknowledgement which means they were sent. No acknowledgement from the FDA.
Please see the attached details in the NUDI Quality Assurance Framework.
