Why So Many Companies in Europe Are Reconsidering Their Traceability and Serialization Providers

The pharmaceutical industry in Europe faces the challenge of meeting strict anti-counterfeiting regulations designed to ensure patient safety. However, in the rush to comply with the European serialization system’s mandatory implementation date of February 2019, many companies opted for quick solutions that, in the long run, have not always been sustainable. Others chose solutions with excessive functionalities and costs compared to the contracting laboratory’s requirements. Today, over five years after the regulation’s implementation, many companies are re-evaluating their traceability providers to find alternatives that are efficient, scalable, and sustainable over time.

Reasons for Migrating to New Serialization and Traceability Providers

Contract reviews have become more common in the sector due to issues such as:

  • High serialization costs, which impact profitability as expenses increase over time.
  • Insufficient customer service that fails to respond quickly to companies’ needs, compromising regulatory and operational compliance.
  • Relative importance of the provider: smaller intermediate laboratories are often dissatisfied with global providers due to the perceived lack of attention they receive.
  • Technological limitations that hinder adaptation to new requirements or increase customization costs.
  • Lack of long-term vision and limited sustainability, driving companies to seek providers capable of guaranteeing an effective, cost-efficient solution over time.

How to Evaluate a Future Serialization and Aggregation Provider

Selecting a Level 4 serialization and traceability provider is key to ensuring a successful transition and improving supply chain control and efficiency. Here are some criteria to correctly evaluate potential candidates:

  1. Proposal Assessment: A Solution Tailored to the Company’s Needs

    A provider should demonstrate an understanding of the company’s needs and a willingness to customize the solution based on factors such as:

    • Type and volume of production
    • Specific production processes and timelines
    • Existing infrastructure and hardware
    • Implementation schedule
    • Total costs and budget

    It is essential for the provider’s proposal to be transparent regarding costs, including direct and indirect costs such as:

    • System maintenance, updates, and support
    • Staff and end-user training
    • Computer validation

    This breakdown allows for more accurate comparison of options and the selection of a solution that offers the best value in both the short and long term.

  2. Quality Technical Support and Assistance

    To ensure operational continuity, the serialization provider should offer efficient technical support, ideally with:

    • Assistance in the same language
    • Extended coverage hours
    • Technicians trained in problem detection and resolution

    Any delay in serialization and traceability can impact product entry into the market, so having a nearby, accessible, and well-prepared team is essential.

  3. Verification of References and Success Stories

    Before making a decision, it is crucial to investigate the provider’s track record. Reviewing references and previous success stories can offer a clear view of their performance in similar situations and provide insight into other clients’ satisfaction. This analysis helps select a reliable provider capable of meeting the specific challenges of the sector.

Benefits of Switching to a New Level 4 and Level 5 Serialization and Traceability Provider

Migrating to a specialized provider can offer significant advantages:

  • Costs aligned with current needs: as risks and unknowns have decreased over time.
  • Greater efficiency and scalability: more advanced solutions enable smooth operations and adaptability to future regulatory changes.
  • Security and continuity: today’s migration processes are secure and do not disrupt data flow or regulatory compliance.
  • Improved post-implementation service: proactive customer support simplifies incident management and ensures a positive user experience.

Conclusion: Towards Efficient and Sustainable Traceability

In Europe, the traceability market has grown in knowledge and experience. Pharmaceutical companies are re-evaluating their options and migrating to Level 4 providers who offer a combination of efficiency, sustainability, and continuous support. This change can make a crucial difference in profitability and long-term regulatory compliance, ensuring robust and efficient processes.

If you want to learn more about how traceability migration can benefit your company, Verifarma is ready to help you find the right solution to optimize your processes.