Manual Serialization SolutionDownload PDF
A Mobile Printer Station for Serialization and Aggregation
EU and US compliant
The Serialization Solution is a mobile printer station for serialization in compliance with the EU and US regulations.
We provide you with a complete solution for serialization and verification of UI and ATD as well as aggregation up to level 2 (item and bundle).
We are also able to advice you on ATD adaption and integration of the system into existing packaging lines.
The Serialization System is available in a manual and a semi-automatic version.
The Falsified Medicine Directive
“To reduce the occasions on which falsified medicines enter the legitimate supply chain” is the aim of the EU Falsified Medicines Directive (2011/62/EU).
The safety measures require wholesale distributers and pharmacists to verify the authenticity and tamper integrety of the medical product and identify individual packs.
By 9th February 2019 all prescription products must be labelled with an UI and an ATD.
Unique Product Identifier (UI)
A two-dimensional barcode and human readable information providing identification and authentication of the individual unit.
Anti-tampering Device (ATD)
Product sealings that make is possible to visually verify whether the outer packaging has been tampered with.
An all-in-one solution
Minimal burden on employees
Authentication of products
Supply chain transparency
Improved product quality
Reduction in non-conformities
Project Execution Plan
Signed contact and User Requirement Specification
Review of Service Level Agreement and Quality Agreement
Ensuring the right documentation for hardware, software and performance
Enabling contact to upload provider
Interested in an serialization solution with a limited amount of work for you?
Please contact me for further information on how to get at started
Principal Consultant GMP & Compliance