Bioterrorism Act Compliance (Protecting your supply chain)
GSQA is an online platform that helps manufacturers exceed record keeping and traceability requirements listed in the Bioterrorism Act, Section 306. GSQA collects and stores lot level data from the ingredient manufacturer, the transporter, and the receiver of goods. This traceability extends to both internal and external suppliers, providing visibility across the supply chain. GSQA gives immediate electronic access to those records, in addition to direct access to the COAs and specifications. GSQA also provides lot tracking to show which of your locations used specified lots, even when distributing intermediate product or raw materials between locations.
Bioterrorism Act Compliance with GSQA
- Instant Traceability – By having all required records in an electronic format in a single system, GSQA enables real time information retrieval.
- Global Access To Local Records – Since GSQA is delivered using a SaaS model, all relevant records can be securely accessed from any computer. This provides a common information platform between the manufacturing plant and corporate headquarters.
- Electronic Transmission – Suppliers using GSQA can use a number of electronic formats to transmit the information, eliminating double entry and streamlining the data entry process.
FDA's Bioterrorism Act Overview
The Bioterrorism Act of 2002 changed the requirements for material information tracking. Section 306 of The Bioterrorism Act requires food manufacturers to produce records in at most, 24 hours (in an emergency situation) for a bevy of information. This data includes lot and transportation traceability for all ingredients and food contact packaging. (www.fda.gov)
Compliance Information Required for Non-Transporters
The required information falls into seven categories:
- The name, address, phone number, fax number and e-mail of the Company's plant who had the product or ingredient immediately before you (the transporter's immediate previous source), and the date you received it from that Company;
- The name, address, phone number, fax number and e-mail of the Transportation Company who delivered the product or ingredient to your Company including the Bill Of Lading Number and mode of transportation;
- The name, address, phone number, fax number and e-mail of the Company's plant who had the product or ingredient immediately after you (the transporter's immediate subsequent recipient), and the date it was delivered it to that Company;
- The name, address, phone number, fax number and e-mail of the Transportation Company who picked up the product or ingredient from your Company including the Bill Of Lading Number and mode of transportation;
- The type of product or ingredient, brand name and specific variety;
- The lot number or other identifier of the product or ingredient if available;
- The type of packaging and quantity per lot;
GSQA provides the tools to demonstrate compliance with these regulations in an electronic format. GSQA eliminates paperwork as well as provides instant and complete visibility across your supply chain.
Bioterrorism Compliance With GSQA
Every material characteristic of every incoming shipment of every lot is tracked. GSQA matches the inbound material characteristics to production yield and finished good quality benchmarks. Suppliers or the receiving plant enter shipping and quality information using several different options:
- EDI / EDI Internet / Secure FTP Connection
- GSQA's intuitive web interface
- Direct connection to a supplier's legacy systems
- Uploads of Bill Of Lading, COAs, and other related documentation
GSQA provides collection and storage for lot level shipment information required by the Bioterrorism Act. This information becomes readily available through a secure online connection, including all of the contact and location information for the shipper and the transporter.
GSQA collects detailed lot data including test results, as communicated by the certificate of analysis.
Inter + Intra Plant Batch and Lot Tracking
GSQA provides lot tracking to show which locations used specified lots, even when distributing intermediate product or raw materials between locations.
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