Traceability
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EU Traceability Regulations Overview

FDA Traceability Regulations Overview

FDA Traceability Regulations Overview

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traceability

What is Traceability?

Simply put, traceability is the ability to trace the history of a product under investigation. “History” refers to all the activities and inputs used in the manufacturing process from raw materials purchase and intake to manufacturing and processing, through to storage and final dispatch.

Why do I need Traceability?

Consumers are becoming increasingly concerned with the safety of products manufactured for human consumption and medical administration. A number of high profile scares and scandals have resulted in declining consumer confidence and the advent of powerful consumer groups. Consequently, the issues of product quality and traceability throughout the manufacturing and supply chain are of increasing concern for manufacturers and statutory bodies.

How can softtrace help companies meet their traceability requirements?

At softtrace, we know that factors at play in the current environment have placed your industry under renewed pressure to:

  • Improve product security, validation rules and safeguards.
  • Achieve the degree of data integration necessary for full, verifiable traceability.
  • Implement risk management and rapid response capabilities.

Demonstrable traceability, crisis management and rapid response capabilities demand immediate access to, and dissemination of, all pertinent information and data. Traceability gaps in areas such as raw materials / ingredients intake, in-process, packing and dispatch, limit your rapid response and product recall capabilities as well as your ability to efficiently meet current and emerging compliance and competitive challenges.

Forward traceability means being able to:

  • Immediately identify all finished product batches containing a contaminated ingredient.
  • Immediately establish their in-store or dispatched location
  • Rapidly instigate product recall.

Backward Traceability means being able to:

  • Receive external notification of a quality breakdown with a product.
  • Easily trace the affected product batch backwards through the process.
  • Instantly identify all associated raw material / ingredient deliveries.

Traceability enables your company to configure an electronic trace path to exactly match the physical path of the business process – from the supply of raw materials through to despatch and distribution.

The individual softtrace modules add up to a factory-wide data collection and management system that affords full product traceability. The degree of data integration provided by the suite sets it apart from anything else currently on the market. softtrace maintains the integrity of the traceability chain and provides effortless access to all data, forward and backward, from any point in the chain.

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