2. The Electronic Laboratory Exchange Network (eLEXNET) had been updated in several key areas in recent years. The New eLEXNET Home Page eCCMS — Communities Reporting and Analysis www.elexnet.com

3. Functions Within eLEXNET

4.  Preparing and submitting samples to eLEXNET  Checking the status of submitted files  Fixing data quality errors and resubmitting samples  Reporting submitted samples to FDA for compliance Considerations for ISO Labs

5. Preparing to submit samples to eLEXNET is a four step process Considerations for ISO Labs The eLEXNET Support Team is available to assist with every step of the process.

6.  Submitting Samples to eLEXNET (Cont.)  Sample data is complicated.  FDA and eLEXNET break a sample into the following six areas, four of which are required*. Sample Information* Sample Lot Action Taken Sample Summary* Test* Test Results*  eLEXNET only requires 16 data attributes to accept a sample.  Additional data increases the value of the sample for analysis. Considerations for ISO Labs New Tools are on the way – Data Exchange Setup Tool (expected late June)

7.  Submitting Samples to eLEXNET (Cont.)  To increase the acceptance of the samples: Contact the Help Desk whenever new Food Products and Analytes are tested by your laboratory.  For labs which have been reporting data to eLEXNET for years: Review how the data is set up and confirm it matches the food testing performed today.  Additional reasons collected values were added to identify the ISO samples: −014 State-FDA Compliance −015 State-FDA Surveillance −016 State-FDA Environmental Considerations for ISO Labs

8.  Checking the Status of Submitted Files Two new tools are available:  Data Submission Confirmation e-mail with an Error Log mailed to primary and secondary Points of Contact Changes underway to allow FERN labs to manage the eLEXNET contacts separately from FERN contacts.  Data Quality Application within the Interactive Data Analysis Tool (IDAT) Displays Error Logs by date Common Errors −Analytes not found; missing Analyte type codes −Product codes not found −Dates out of sequence −City/State/Zip Code Considerations for ISO Labs Use this information to correct data and resubmit.

9.  Reporting Submitted Samples to FDA for Compliance  IDAT There are many ways to generate a lab specific report of samples within a specific time period in the Sample Analysis Application (IDAT). Reports can be bookmarked and used in the future.  Business Objects Easy to setup and save Not as intuitive as IDAT  Plan Early Avoid waiting until reports are due before contacting the Help Desk. Considerations for ISO Labs

10. eLEXNET URL: www.elexnet.com eLEXNET Help Desk elexnet_help@fda.hhs.gov.com Tel: (301) 770-4012 | Fax: (301) 770-4013 Contact Information

11.  Now for the Demo…  Dr. Eyal Rand, eLEXNET Senior Analyst Questions