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PLG, Inc. provides professional services to the Life Sciences Industry. Founded in 2001, we have applied project management principles and subject matter expertise in the areas of Regulatory Compliance and Track and Trace solutions.  

    Track and Trace Solutions

 

           Program Management

           On-Site Project Leadership

           Regulatory Compliance

           Track and Trace Solutions

PLG combines a project management approach with proven subject matter expertise in the area of Track and Trace. The ultimate goal of Track and Trace is enhanced patient safety and product integrity. Track and Trace is the process of serializing a product and capturing its status as it moves through the supply chain, ultimately resulting in a secure chain of custody.  While California Track and Trace legislation has been the initial driver, the interpretation that will be used for enforcement is still open for industry discussion. Furthermore, there is draft legislation underway at the Federal level. As a result, industry adoption activities have been mixed. Is Life Sciences ready to comply with Track and Trace?

Track and Trace is the process of serializing a product and capturing its status as it moves through the supply chain:

  • Track: determining current location of products in the supply chain
  • Trace: identifying the history of where a product has been
  • Serialization: a scheme for identifying individual packages
  • Pedigree: a certified record of the chain of custody of a uniquely identified product as it moves through the supply chain

The industry’s product offerings must comply with global Track and Trace requirements for the markets it serves. Supply chain systems must deliver product to customers in critical markets with a new level of visibility. PLG provides proven subject matter expertise to define and implement end-to-end, cross-functional, business-centric requirements which are cornerstones of a Track and Trace strategy:

  • Legislation and industry knowledge
  • Serialization
  • GS1 standards
  • Vendor capability assessment
  • Manufacturing line pilots and conversions
  • Distribution enablement
  • IT integration strategy
  • Trading partner collaboration
  • Financial planning and management
  • Strategies to fulfill diverse worldwide requirements

The Life Sciences industry supply chain of the future must be compliant, effective, and efficient. PLG enables Life Sciences companies to leverage and optimize business value to realize a return on investment while achieving Track and Trace compliance. 

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