Serialization & Traceability

Expert insights from ideation through implementation

technician hands scanning barcodes on biological sample tube in the lab of blood bank

Pharmaceutical Serialization and Traceability Experts

The mandates of the Drug Supply Chain Security Act (DSCSA) and European Falsified Medicines Directive (FMD) have brought pharmaceutical serialization top of mind for major life sciences companies. Meeting FDA and EU serialization requirements has never been more critical, time-sensitive and complex.

 

Adept Packaging engineers thoroughly understand the complexity of serialization and traceability, thanks to many successful implementations with both Pharmaceutical companies, as well as at CMOs and CPOs. We have a proven track record helping our clients in this industry implement serialization and develop traceability strategies for end-to-end supply chain visibility. Our team of experts provides insights for our clients to avoid expensive pitfalls and ensure serialization and traceability implementations are done right the first time.

Serialization Strategy

Our team of experts will collaborate with your team to develop a serialization compliance strategy that encompasses:

 

  • Project Governance structure
  • Serialization rollout planning
  • Resource planning

Implementation Support

You can rely on our deep expertise for all aspects of your serialization program:

 

  • URS and FS development
  • FAT, SAT, IQOQ execution
  • Installation & configuration of IT components

Expert Insights

Our engineers provide subject matter and technical project experience to:

 

  • Develop serialization implementation plans
  • Develop traceability strategies
  • Manage internal and external resources
  • Manage IT components and suppliers

Serialization Training

We offer focused, serialization-specific training.

Level 1: Basic Training

 

Introduction to serialization concepts, regulations and standards.

Level 2: Advanced Training

 

For individuals working on serialization projects, providing an in-depth review of global requirements, artwork changes and process changes.

 Level 3: Use Case Training

 

For project managers, line operators and IT professionals involved in the implementation of serialization, level 3 covers packaging line scenarios, and provides an in-depth review of all the serialization use cases, process changes, SOP updates and impacts to the packaging line and IT systems.

Adept Packaging is working as a proud partner with TraceLink to apply our blended expertise to improve the serialization experience for our clients.

Learn How We Simplify Serialization

View The Whitepaper