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Fluid Edge Themes

FSMA: FSVP Compliance Module

Good Record Keeping and Document Compliance, Integrated and Affordable Across the Entire Supply Chain

Were you identified on the FDA’s FSVP Importer List? Then you’re in the right place!

Tame your Foreign Supplier Verification Program

(without making it a full-time job)

Good recordkeeping to document compliance with the FSVP rule will be key to having a good result when FDA inspects an FSVP importer. 

FSVP will be much more than a compliance checklist. Importers of food will need systems created to account for suppliers with varying degrees of technological capabilities as well as the perishable nature of the goods at hand. These types of supply chains have numerous uncertainties and potential disruptions, as the importers must largely consider uncertain factors like weather, natural disasters, fluctuating commodity prices, and more.

Data management systems are imperative, and all spects of the supply chain will require a solution that is affordable, efficient, and transparent, from the smallest foreign supplier to the largest international buyer.

az-fsvp-mod-desktop

Add and organize your suppliers, define hierarchy, and open channels of fluid document communication across your foreign supply chain. (Templates available!)

Collect, store, and share records relating to processes and procedures, including the results of evaluations and determinations conducted.

In a few clicks, create an FDA Package report to send FVSP records to the FDA. (Especially useful tool during FDA inspections)

Valuable information is integrated for your use in evaluating your program and suppliers (warning letters, recalls, and status of inspections).

Start with your Qualified Individual(s)

You may easily add sub-users to your account to help manage your supply chain, compliance, documentation, and/or other modules. To help with your FSMA reporting, we’ve added the ability to easily designate sub-users as Qualified Individuals. With this option selected, you may add qualifying credentials that may be included in your reporting to FDA, such as resumes, college transcripts, QI trainings, and more.

Better yet, your suppliers may add their QIs as well, allowing you the ability to see what document, supplier, and product approval decisions were made by who, and whether they were qualified to do so under the parameters set by FDA and FSMA.

Build Your FSVP Compliance Program

More than a simple spreadsheet, Azzule’s FSVP module not only lists documents per supplier, but houses them as your suppliers begin to transfer their completed documentation.

Use the default FSVP verification activities list or select custom options. Use templates available, such as FSVP SOPs, Hazard Analyses, and more to jump start your program development. See which documents you’ve collected and/or, more importantly, see what’s missing at-a-glance!

Especially helpful, is the “FDA Package Report” feature which allows you to package and export your entire FSVP program with one click. Send to the FDA or download in seconds during an FDA inspection.

Build a Living Supply Chain

An affordable software providing you, your suppliers, and their suppliers an interconnected supply chain environment for document sharing. Organize your supply chain, define hierarchy, collect and store documents, and fully develop a living FSVP program.

Track Approval of Suppliers, Products, & Documentation

An affordable software providing you, your suppliers, and their suppliers an interconnected supply chain environment for document sharing. Organize your supply chain, define hierarchy, collect and store documents, and fully develop a living FSVP program.

FDA Package Report

 
With one click, package and export your FVSP records to send to the FDA.
The FDA will request importers to provide records within 24 hours. This may be an especially useful tool during FDA inspections.