Traceability
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EU Traceability Regulations Overview

FDA Traceability Regulations Overview

FDA Traceability Regulations Overview


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With increasing concerns over food origins and safety, both EU and FDA regulatory bodies are tightening controls & requirements and enforcing manufacturers - particularly in area of food production - to be able to prove compliance to strict traceability and quality management information regulations.
Consumers are also very aware of the risks in today’s environments and are constantly looking for re-assurance to increase their confidence levels in manufacturers’ products.

At softtrace we have developed solutions for many manufacturing industry environments to assist in complying with these ever changing EU and FDA regulations which also assist you in achieving a rapid Return On Investment (ROI) by reducing overhead costs, managing your yields and allowing you to make proactive production management decisions through the availability of real-time live data throughout the manufacturing process.

A vital component of our solutions is the ability to interface with existing instrumentation and other ERP and third party products to gather data, and share where necessary, allowing us to pool the required data into a central repository which can be accessed throughout the plant.

Our unique user access and security functionality ensures you can, not only manage the ownership of the data, but be confident of its integrity through strict data management audit trails on every user action.

Our solutions are completely configurable to allow you to mimic your existing paper-based process flow and manage your data, and data sheets, easily and effectively. The ability to easily configure the solutions to tailor your exact requirements, allows the user the flexibility and scope to maintain and manage the solution to conform to their changing needs.

All softtrace solutions are Windows based applications with the server end running on Windows 2003/2008 Server and the client running on Windows XP Pro or Windows 7 Pro. The client end of the system will also operate on Windows Terminal Services or Citrix.

Oracle versions 9, 10 and 11g are available, as well as Microsoft SQL version 2000, 2005 & 2008.

Installing softtrace product solutions will ensure compliance with:

  • EU 178/2002 Food Traceability Requirements
  • EU 1935/2004 Food Contact Materials Traceability
       Requirements (applicable from October 2006)
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