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

Functi ons Within eLEXNET

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

Considerati ons for ISO Labs

Preparing to submit samples to eLEXNET is a four step process

Considerati ons for ISO Labs

The eLEXNET Support Team

is available to assist with every step of the process.

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.

Considerati ons for ISO Labs

New Tools are on the way – Data Exchange Setup Tool (expected late June)

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

Considerati ons for ISO Labs

Checking the Status of Submitted FilesTwo 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

Considerati ons for ISO Labs

Use this information to correct data and resubmit.

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.

Considerati ons for ISO Labs

eLEXNET URL: www.elexnet.com

eLEXNET Help Deskelexnet_help@fda.hhs.gov.com

Tel: (301) 770-4012 | Fax: (301) 770-4013

Contact Informati on

Now for the Demo… Dr. Eyal Rand, eLEXNET Senior Analyst

Questi ons