Serialization & Traceability

Driving compliance with successful serialization and traceability programs for your supply chain.

technician hands scanning barcodes on biological sample tube in the lab of blood bank
Does your serialization and traceability program account for the complexities of the current and ever-evolving standards and regulations? Is your current serialization and traceability program optimized to meet your operational needs?

 

The mandates from US, Europe and more recently also Russia, in conjunction with the growing body of other market specific requirements, have elevated pharmaceutical serialization to a top compliance concern for major life sciences companies. Meeting these serialization requirements has never been more critical, time-sensitive and or complex.

What Adept offers:

Deep Expertise: Our experienced engineers and project managers will apply their subject matter expertise and technical project proficiency guide you with insights from ideation through implementation and optimization.

 

Risk Reduction and Cost Optimization: Adept can manage your internal and external resources along with IT components and suppliers to help avoid expensive pitfalls and ensure serialization and traceability implementations are done right the first time.

 

Reduced Time to Implementation: We also reduce the stress on businesses to find the adequate people for the time needed to implement those solutions and provide short term and long-term service for those.

 

Continued ROI: In addition, we help businesses to understand how to gain benefits from their investments in those new functions and how to use the systems more effectively.

Getting Started:

Collaborate with our team of experts to develop a serialization compliance strategy that encompasses:

  • Project governance
  • Risk-based product security strategies
  • Internal and external packaging serialization capabilities assessments
  • Risk-based serialization rollout planning
  • Resource planning
  • IT serialization architecture

Program Execution:

Program Execution:

You can rely on our expertise for managing and executing all aspects of your serialization program, including:

  • Project Management
  • Packaging line assessments
  • Package artwork evaluations
  • Equipment and software selection
  • URS and FS development
  • Validation and qualification (FAT, SAT & IOQ execution)
  • Installation & configuration of IT components
  • Accelerators: CMO ProTrack

Program Optimization:

Increase your return on investment as Adept provides an in-depth assessment of your existing serialization and traceability programs:

  • Process gap analysis
  • Hardware and software upgrade roadmaps
  • Business process sustainability
  • Solution migration management
  • Smart Packaging
  • IoT
  • Blockchain

Training Services

Adept provides customized training to get your organization up to speed with all aspects of pharmaceutical serialization:

Serialization For Manufacturers and Distributors:

Our training program is organized in three levels of increasing depth and focus: Basic, Advance and Expert. Each level is designed to address all aspects of serialization and traceability in the manufacturing and distribution environments. Topics range from introduction to serialization concepts, standards, and regulations, passing through deep dives for automation, engineering and technical services individuals, and culminating in packaging line and distribution real-life scenarios.

Market Specific Regulation Workshops:

Facilitator led regulatory workshops are designed to instruct your teams in the specific requirements enacted by your target market. Each workshop includes a through gap assessment of your firm’s readiness state by our engineering staff. Target market regulations include:

 

DSCSA (USA)   •   FMD (Europe)   •   Russia   •   South Korea   •   Turkey   •   Brazil

Knowledge Management:

Our consulting practice maintains a library of comprehensive specification document covering all relevant regulatory mandates and industry standard guidelines applicable to product serialization. These specification documents are organized in easy to follow tables with graphical aids and examples.

DSCSA Workshop for Dispensers (Clinics, Pharmacies and Hospitals):

DSCSA Workshop for Dispensers (Clinics, Pharmacies and Hospitals) – This facilitator led workshops is designed to instruct your teams in the DSCSA requirements applicable to dispensing operations along with an assessment of your firm’s readiness state by our engineering staff.

Learn More About:

Adept Packaging is a proud partner of TraceLink. We apply our blended expertise to improve the serialization experience for our clients.

Learn How We Simplify Serialization

View The Whitepaper