Macsa ID UK Ltd has launched its Serial Pharma software, one of the first certified solutions to integrate its advanced marking equipment, data matrix code reading and control of alphanumerical digits in accordance with the EU Falsified Medical Directive 2011/62/EU (FMD).
The FMD regulation, which came into effect in February 2019, 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 powerful and reliable serialisation and traceability solution. It manages via an ERP system manufacturing orders, unit marking equipment, code readers and viewing cameras to control from marking to database registry, and meeting the requirements of FMD and 21 CFR Part 11.
The Serial Pharma solution comprises 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 data base 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 ERP’s.
Macsa ID provides pharmaceutical industry customers with coding and marking technology to meet their traceability and identification needs. It offers hardware, project management, software, consumables, spare parts and technical service.
The company’s equipment, which includes laser coders, large character high resolution ink jet technology (LCP), small thermal inkjet (TIJ) and labelling systems such as print and apply, is ideal for blister packs, cases, boxes and pallets
In addition, the company has designed customised solutions and applications for management software for marking and coding processes. Macsa ID’s Serial Pharma software was developed as a result of this experience, the first global solution to ensure the pharmaceutical production line adheres to FMD.