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Solution Overview: Serialization & Traceability

With regulatory requirements looming and a growing desire to prevent counterfeiting, tampering, theft, and diversion, companies must begin to look at Serialization and Track & Trace solutions to better control the chain of custody in their supply chain. Solutions such as SAP Auto-Id and Object Event Repository, also known as AIE, provide companies with robust solutions to address these challenges.

Clarkston Approach & Methodology

Clarkston’s methodology provides a systematic approach to implementing these solutions:

Proof of Concept
Once traditional project startup tasks have been completed, functional requirements are gathered and approved. During Proof of Concept, these requirements are configured and the systems are installed and connected. Collaborative tasks include:

  • Gather requirements
  • Develop functional specifications
  • Install SAP ERP/ECC and SAP AIE (PI, OER, Aii)
  • Connect to MES server and packaging lines
  • Install bar-coding scanning system(s)
  • Test Serialization processes
  • Sign-off Proof of Concept

Engineering Trials
The next phase supplies the Track & Trace functionality. Clarkston installs and tests on both a functional and technical level to ensure business and system functions are in line. Key steps include:

  • Configure Track & Trace processes
  • Verify processes through bar-code scanning and shipping station
  • Establish reporting
  • Perform unit and integration tests
  • Test Serialization and Traceability processes
  • Develop validation master plan
  • Sign-off Engineering Trials

Prior to system start-up, Clarkston ensures that systems are properly validated to assure both appropriate functionality and regulatory compliance.

  • Migrate solution to quality testing environment
  • Execute validation master plan (Global AIE, MES, and packaging line)
  • Fully test AIE systems
  • Update impacted SOPs
  • Perform knowledge transfer
  • Develop cutover plan
  • Sign-off Validation

Go-Live and Roll-out Strategy
Once the solutions have been developed, tested, and validated, Clarkston and the client develop a go-live and roll-out strategy. Training, change management, and all documentation, including lessons learned, benefit implementation and future rollouts to manufacturing lines, contract manufacturers, and warehouse facilities.

For more, please download our report.

Tags: Serialization & Traceability