Our team specializes in product security solutions (serialization, track&trace) as well as batch traceability.
We have many years of experience with customers in the pharmaceutical industry, with a specialty in implementing SAP solutions in logistics / traceability:
- SAP GBT (Global Batch Traceability)
- SAP ATTP (Advanced Track and Trace for Pharmaceuticals)
- SAP Aii/OER (Serialization, Track&Trace solution from SAP)
- SAP ECC supply chain management (procurement/distribution/manufacturing)
as well as integration to cloud solution providers: e.g. SAP ICH, TraceLink
Our Track & Trace Projects:
Serialization / Track & Trace, current projects
Track and trace implementation for Russia for all pharmaceutical products with the special requirement to assign each product its serial number and cryptographic code. Besides applying crypto code on each pack, the reporting requirements to record package's movement through the supply chain are very complex.
Implementation of US DSCSA 2019 - for sellable returns using SAP ICH und Blockchain technology.
Serialization / Track & Trace, 2018 - 2019
Implementation of the European Falsified Medicines Directive (FMD), Serialization for South Korea, US, SA. Connection to global IT systems as well as data exchain to supply chain partners and health authority systems.
Serialization / Track & Trace, 2013 - 2017
Solution evaluation, design and implementation for external partner integration (Contract Packagers, 3PL, Wholesalers, DC, MAH) using a cloud solution provider. Solution is fully integrated into the serialization and ERP system of the pharmaceutical customer.
Solution architecture design to comply with US DSCSA, Eu EMV, Russian pilot.
Batch Tracing, 2015 - 2017
IImplementation of a global harmonized batch traceability system (SAP GBT 2.0). Requirement definition, process analysis, design, test and documentation. Integration of multiple SAP ERP systems, as well as non-SAP systems (project was initiated to comply with EU GMP Regulations Annex 16).
Batch Tracing, 2012 - 2014
Implementation of a global batch traceability system (SAP GBT 1.0). Responsible for the technical design and timely implementation. Integration into 16 SAP ERP instances.
Serialization / Track & Trace, multiple customer projects 2006 - 2014
Implementation of global IT solutions to comply with regulatory requirements in the area of product security and traceability: e.g. California pedigree, TR, CN. Responsible for technical solution evaluation, design and implementation for multiple pharmaceutical companies.
Labeling / Supply Chain 2002 - 2006
Global launch of a compatible labeling and barcode system to ensure product and batch identification and to comply with regulatory requirements.