Because of the rising amount of the counterfeit drugs, in 2016 the Delegated Act on safety features was published, introducing tough laws that enable harmonized, European-wide measures to rigorously control the safety and supply of medicines for human use.

Directive 2011/62/EU introduces obligatory “safety features” – a unique identifier and an anti-tampering device – to allow the verification of the authenticity of medicinal products subject to prescription and protect patients and business alike from the risks of falsified medicines.

The above mentioned “safety features” are what is referred to as Serialization.

Currently serialization is implemented in the Pharmaceutical industry, however, in the near future it will also be applicable to the medical devices industry.

We also validate serialization software based on cloud solutions (IaaS and / or SaaS).

Leveraging on our knowledge of Computerized System Validation and understanding of production and packaging processes in the pharmaceutical industry, we validate the complete serialization solution.

Validation of serialization solution concerns:

Qualification of new packaging equipment (print and verify equipment, tamper evident device)

Validation of serialization
system from L1 to L4

Validation of interfaces
between the L4 system and L5
(EU Hub)

Validation of interfaces
between the L4 system and ERP system

Find out how our validation experts can support you