Serialization & Technology

Adept Packaging Makes Serialization Programs Successful

Serialization Services & Technology

Serialization and traceability are becoming increasingly prevalent in the Pharmaceutical, Medical Device and most recently, Food, Beverage and CPG industries. The main drivers for Pharmaceutical Serialization services are the global Serialization mandates and the close Serialization deadlines – November 2017 in the US, and February 2019 in EU. In addition, several regulations have been enacted in China, Turkey and South Korea, and set of new directives encompassing Middle Eastern countries are expected to be released soon. However, compliance is not the only driver for Serialization. Across industries, companies are embracing Traceability for its value in securing the supply chain, reducing counterfeit and improving patient and consumer safety.

Adept Packaging has 3 major focus areas for Serialization and traceability:

  • Serialization Services for Pharma Companies, comprising of Serialization implementation support, Serialization project management and Serialization training
  • Serialization services for CMOs and CPOs – quick compliance
  • Serialization and Technology Subject Matter Expertise

Serialization Services

Adept Packaging Serialization services focus on 3 key areas to help our clients achieve Serialization compliance and generate value from traceability:

Program Management

Serialization programs require effective coordination of internal and external resources. Adept Packaging has specialized experience in:
o Packaging Line Automation
o Hardware & Software management
o External Supply and CMO Management
o Automatic Identification
o Regulatory Requirements
o Data Capture
Whether coordinating external resources or supplying internal resources, Adept Packaging engineers and project managers provide the right combination of Serialization subject matter expertise and project management skills to ensure your investment in compliance is successful. Our engineers serve as our clients’ program management office (PMO).

Line Implementation Support

We understand the resource constraints of today’s Pharmaceutical companies. It can be costly to hire full-time Serialization specialists and it is also difficult to recruit for this precise field of expertise. Adept Packaging engineers are experienced in all aspects of Serialization from assessment and architecture through the implementation of Serialization on the packaging line, including installation qualification and post-implementation support. We also help our clients develop their packaging line automation strategy. Adept Packaging is there every step of the way to ensure that line implementation is efficient and successful.

Regulations and Deadlines

The Serialization deadlines that are on everyone’s minds are November 2017 for the United States and February 2019 for Europe. Many companies do not realize the time commitment necessary for implementing Serialization and are late in starting. Adept Packaging works with clients to ensure they are getting it done right the first time. Our team of experts stays current on the latest regulatory mandates (to ensure coding and identification requirements are up to date and our clients have the latest technology and information) that require coding and identification pertaining to Serialization, ensuring our clients stay on track.

 

Serialization and Traceability Training

Serialization and Traceability regulations impact nearly all of Adept Packaging clients’ business processes. Adept Packaging offers training so clients can stay apprised of ever-changing regulations, learn the details of Serialization standards and fully understand the impact of Serialization on their products, processes and systems. Our training follows a modular, standardized, approach, which can be delivered with agility to ensure Adept Packaging clients are prepared to manage the significant investment of time and money to achieve compliance.

There are three levels of Serialization training:

  • Basic Training- Serialization concepts, standards and regulations
  • Advanced Training- Serialization deep dive of packaging and IT
  • Expert- Serialization process training on the packaging line

 

Serialization & Technology Expertise

To facilitate our Serialization services, Adept Packaging engineers have a broad range of expertise in the following areas:

Packaging Line Automation

  • PLC to Serialization system connection and communication configuration
  • Software and Hardware interface setups and testing
  • Network, XML and OPC communication configurations
  • I/O signal exchange design, testing and signal quality assessments

Serialization and IT Services

  • Installation and configuration of Site Level Serialization IT components
  • Connection and Import/Export tests for HTTP, IIS, Soap and B2MML interfaces
  • Server SW installation and SW installation verification
  • SQL DB installation and configuration

Documentation Services

  • URS and FS development and writing
  • Artwork and label design support for serialization
  • FAT documentation (vendor FAT test combinations and FATclient formatting)
  • SAT documentation
  • IQOQ documentation
  • UIT support documentation
  • SOP development and testing

External Supply and Contract Manufacturing / Packaging Serialization Management

  • Strategy alignment, governance, roles and responsibilities
  • Requirements definition and documentation
  • Implementation rollout planning at External Manufacturers
  • Serialization vendors program management
  • 3rd party or CMO data integration

 

 

 

 

 

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Serialization & Technology Brochure for download.

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Impact of Track and Trace on Pharma Production Article Download

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Securing Pharmaceutical Supply Chain Article

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Download: Serialization Readiness at CMOs and CPOs