Implementing drug traceability is a long, costly and complex undertaking. This makes it even more important to choose the right solution and a partner that meets your needs. In this article, we seek to clarify some major steps that will impact the process of implementing traceability systems in your production lines.

níveis da rastreabilidade de medicamentos

CHOOSING YOUR SUPPLIER

The choice of supplier will be the first major challenge for any company, primarily because drug traceability is a major investment that impacts on the performance of your production lines Choice of supplier is crucial in getting the project to progress as smoothly as possible: remember to include representatives of all the departments that will be impacted by the implementation of traceability in the selection process. Having a working group is extremely important for determining the capabilities needed for a solution and for developing a full user requirement specification (URS).

Once the URS has been developed and conversations with the market have begun, pay attention to the professionals offered by potential suppliers. Do they have previous experience in serialization and traceability projects? Is the team made up of professionals in project management, installation and after-sales service? Get to understand the make-up and history of the team that will do the work on your production line.

níveis da rastreabilidade de medicamentos

PERFORMING A TECHNICAL COMPARISON

Quotations from traceability providers come in different formats and with differing specifications. That sometimes makes it difficult to compare the solutions offered. Performing a technical comparison of suppliers is an important step to ensuring that you are getting the best return on your investment. Here we put together some questions to put to suppliers in order to ensure more transparency between your tenders:

  • Will I need to perform the carton alignment on the conveyor belt? Is this included in the cost?
  • Will I need feeders or special belt guides? Is this included in the cost?
  • Will I need an additional conveyor belt? Is this included in the cost?
  • Do you provide functional specifications?
  • Do you provide matrix validations?
  • Do you provide validation packages?
  • What languages do you provide documents in?
  • What are the brands of the solution components (engine, relays, contactors, etc.)?
  • Will I get local support?

TIP: We know that a complete traceability solution runs from level 1 to level 5. This means that some companies might choose to implement traceability in stages, or with different suppliers providing the handover of different levels. There are some disadvantages to this:

  • stopping the production line more than once;
  • bearing the additional cost of integration between the systems of different suppliers;
  • predicting the additional time needed for developing connections.

 

Download the Drug Traceability Guide

PREPARE YOUR INFRASTRUCTURE

When implementing the serialization project, the most important points are normally related to infrastructure, such as feeding points for the panels, network infrastructure for connecting the system to the company network, compressed air points for the relevant stations, etc. Preparation of this kind is very helpful: once the mechanical and electrical integration is completed, you are in a position to power up and start testing the system. In addition, preparation prevents having parallel work fronts, which, depending on the physical space or environment, could hamper the progress of the project.

With the mechanical side ready and the cable interconnections generally made, the second most important step is to getting the involvement of those responsible for the equipment with which our system will be interlinked – such as case packers, cartoning machines, sealing machines, check weighers, etc. In some cases, there may be signaling changes, making it necessary to reprogram the equipment.

 

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