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Serialization and Traceability

Driving successful serialization and traceability programs for your supply chain

Serialization and Traceability

Driving successful serialization and traceability programs for your supply chain

Does your serialization and traceability program meet 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 (Drug Supply Chain Security Act – DSCSA), Europe (European Falsified Medicines Directive – FMD) and more recently also Russia (Federal Law No. 425 FZ and Decree 1556), together with the growing body of other market specific requirements, have brought pharmaceutical serialization as a top compliance concern for major life sciences companies. Meeting these serialization requirements has never been more critical, time-sensitive and complex. Let our pharmaceutical serialization and traceability experts guide you with insights from ideation through implementation and optimization.

What Adept Offers

Our experienced engineers and project managers will apply their subject matter and technical project proficiency to develop your serialization plans and traceability strategies. 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.

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. 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 effective.

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

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 throrugh 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 specifcation documents are organized in easy to follow tables with graphical aids and examples.

adept-icon-workshops

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.

Adept MDLP Demo

Bridging the Gap to Russian Serialization Compliance

Most of the large IT providers will not be fully compliant with these new requirements by the 2020 deadline. Is your company at risk?

With the Russian Serialization deadline quickly approaching, many companies have recently found out their at risk of non-compliance. Most of the large IT providers such as TraceLink and SAP will not be fully compliant with all these requirements by the January, 1 2020 deadline.

In order to bridge the gap between your current IT provider and Russian compliance, we’ve developed Adept MDLP. The Adept MDLP solution will supplement any of the reports that will not be ready on time with your main IT provider. Once the reports you need are identified, the Adept Digital team will develop Russian-compliant XML files to be uploaded to the MDLP hub. Our serialization experts paired with our customizable solution offer a time sensitive way to ensure the Russian requirements will not pose a risk to your compliance.

Want more information?

Check out our Resource Library

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