Intelligent Agents for FDA Regulated Materials Tracking and Traceability

Cosmetics

Food & Beverage

Pharmaceutical

Medical Supplies

iMTATs
Intelligent Materials Tracking and Traceability Software
for FDA Regulated Applications

Cosmetics	Food & Beverage
Pharmaceutical	Medical Supplies

The US Food and Drug Administration (FDA) now regulates over 22% of all goods sold at retail in the USA, amounting to over $2.8 Trillion of products sold at retail per year.

This includes:

• Foods, Beverages, and Supplements

• Medical Supplies and Devices

• Pharmaceutical Drugs

• Cosmetics

• Biologics

• Blood and DNA products

• Anything that comes into contact with the human body, such as bandages or suntan lotion.

• Anything used in the manufacture or packaging of any of the above items

As a result, an ever increasing number of manufacturers and distributors are finding themselves coming under the jurisdiction of the FDA, as some or all of the products they sell end-up being used in FDA regulated applications.

These regulations require detailed tracking of materials as they are received, inspected, put away,  transformed into products, and then picked, packed and shipped. Then this event tracking data has to be integrated with traceability data received from suppliers and sent to downstream customers and suppliers.

Manually complying with these requirements quickly becomes an overwhelming labor intensive and error prone set of tasks which are best delegated to intelligent agents.  These intelligent agents can also examine the tracking and traceability data to detect counterfeit, contaminated, and potentially hazardous materials and automatically alert managers when this occurs.

As these FDA regulated requirements require both materials tracking and intelligent information exchange with supply change partners, Smart Operations Management offers a specially integrated version of SmartOps24x7 and the WIPtracker tracking and traceability software, called iMTATs™, for Intelligent Materials Tracking and Traceability Software.

The purpose of iMATs is to provide an affordable solution, to enable manufacturers and distributors to comply with the materials tracking and traceability, barcode labeling, and supply chain data exchange requirements of the following acts and regulations:

• The Federal Food, Drug, and Cosmetic Act (FFDCA)
• The Fair Packaging and Labeling Act (FPLA)
• The Food Safety Modernization Act (FSMA)
• The Drug Supply Chain Safety Act (DSCSA)
• The Modernization of Cosmetics Regulation Act (MoCRA)
• Safe Quality Foods Certification (SQF)
• Hazard Analysis and Critical Control Point (HAACP)
• Bioterrorism Act of 2002

iMTATS is CFR 21 Part 11 compliant enabling it to be used for materials tracking in an FDA regulated laboratory, pharmaceutical processing and similar situations.

For more details, please see www.iMTATS.com

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