FSMA 204 Compliance

Check out our FSMA 204 compliance gap analysis and services

FSMA 204 readiness services:

AssessIT FSMA 204 Onsite Assessment

FSMA 204 Training

A detailed explanation of the FSMA 204 rule and available support resources
Industry trends on the path to FSMA 204 compliance (challenges, successes, learnings, et al.)

AssessIT FSMA 204 Gap Analysis

Travel onsite to one or more locations to perform a detailed gap analysis published in a document with relevant photos, reports, charts, to document areas for improvement.
Assessment of your current state operations (including photos of operations, labels, & system reports)
A detailed gap analysis for FSMA 204 regulatory compliance by operational area: Receiving, Production, Shipping
A detailed gap analysis for FSMA 204 regulatory compliance of information systems

Recommendations

Document detailed recommendations for next steps

Ongoing Consulting Retainer Services

We can also provide the following expert consulting services outlined below to ensure your compliance by the FSMA 204 FDA enforcement date. This engagement will help ensure that your traceability systems provide accurate and timely information about product origins and quality, thus enabling them to meet regulatory and supply chain partner requirements. Erik Larsen, a seasoned agriculture industry veteran, will be the primary resource for this engagement.

Expert On-Call

Erik has over 25 years of experience as a leader in the fresh produce industry including: information technology leadership, industry association leadership, EDI and ERP implementations, and FSMA 204 expert advisory to suppliers, processors, and retailers. He is ready to give you truly independent consultation on the most effective solution for your organization.

Implementation Services

Support your team to understand the results of the AssessIT FSMA 204 gap analysis report
Support the development of your FSMA 204 compliant traceability plan
Support your team for the future state system design including system process flow diagramming
Project Management
Software Systems Business Requirements Documentation
Ensure effective data capture, storage and sharing of FSMA 204 Key Data Elements (KDE’s) for each Critical Tracking Event (CTE)

Communications with Suppliers and Customers

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Navigating data requests from your customers
Support development of new supplier data requirements
Create communications to suppliers and customers

Ensure your FSMA 204 Path to Compliance is a success. Partner with us to ensure full compliance!

Get FSMA 204 Compliant!