New software helps brand owners meet FMD serialisation demands

25 Apr 2019

Macsa ID UK Ltd has launched its Serial Pharma software which is one of the first certified solutions to integrate its marking equipment, data matrix code reading and control of alphanumerical digits in accordance with the EU Falsified Medical Directive (FMD).

The FMD regulation, which came into effect in February this year, aims to prevent the entry of falsified products into the supply chain. It applies to pharmaceutical manufacturers, importers, third party packaging and wholesale drug distributors at EU level, as well as pharmaceutical producers of active ingredients that supply EU companies.

As a result, prescription drugs must include a unique, legible unit item serialisation number readable by the human eye and data readers using a 2D barcode data matrix. These packs must be equipped with tamperproof systems of identification and authenticity in their outer packaging.

Serial Pharma is the result of an agreement between Macsa ID and Adents, a serialisation and traceability solution. This solution is made up of a number of key phases: consultancy and advice regarding the choice of systems and equipment, and control and management of marking machines; 2D code reading and print quality control; OCR/OCV viewing for validating humanly readable alphanumeric digits and PLC line communications.

It also offers database management for compliance with FMD.

The main functions of Serial Pharma include management of packaging orders, serialisation in multiple lines, management and/or generation of serial numbers, coding in different formats, aggregation, rework management and user management in line with 21 CFR Part 11.

It also offers in-depth reporting and monitoring with historical query screen, storage registry of data in SQL database systems and integration with SAP and other ERPs.

01462 816091