Prisym develops labeling system for animal health sector

Animal health company Merial has installed the Prisym Medica labeling software at its manufacturing sites near Lyon and Toulouse, France.

Prisym, a labeling and auto-identification solutions provider, was chosen by Merial to provide a secure labeling system which would comply with pharmaceutical regulations worldwide, in particular FDA 21 CFR part 11 rules and the policies of the International Federation for Animal Health (IFAH) regarding the use of two-dimensional codes.

Jean-Claude Muller, director of global supply chain support at Merial and chairman of the global traceability core team of the IFAH, explained: ‘With more than 4,000 different pharmaceutical and biological products, we needed a system that could be compliant with all possible pharmaceutical regulations worldwide. Prisym Medica was the only software we found that was able to be validated for the FDA’s CFR21 Part 11 regulations.’

As well as installing its Prisym Medica software, Prisym also created a module especially for Merial to fall in line with the IFAH’s agreed global standard on 2D Datamatrix codes. The module takes important data such as Global Trade Identification Number (GTIN), expiry date, batch number and quantity, and puts it into a special two-dimensional code. The 2D code, which all IFAH members will soon be required to feature on products, is able to hold more information than conventional barcodes and allows a product to be traced throughout the supply chain.      

The Prisym Medica software, along with the 2D Datamatrix code module is being used to drive up to 40 printers in Merial’s Lyon plant and 20 printers in Toulouse for in line printing of regulatory data on labels and cartons. 

‘Taking a leading position in the traceability initiative agreed by the IFAH, we worked closely with Prisym to develop the 2D Datamatrix ECC200 feature. The project has been extremely successful and the system has now been tested and validated with Prisym’s support,’ added Jean-Claude.          

Prisym Medica label design and production software is specifically developed to meet the FDA’s current requirements, in particular 21 CFR Part 11 compliance. Available as a client/server-based application or as a single workstation version, the software uses high levels of security and data encryption to ensure systems integrity and regulatory compliance at all times. It is able to record critical activities and electronically links them to individual users, along with time and date stamping.

Prisym Medica provides a secure environment for label design, approval, automatic gathering of variable data and label printing. It is developed, tested and documented in accordance with strict FDA and GAMP (Good Automated Manufacturing Practice) guidelines and supplied with full life cycle documentation. The system can be integrated with many other software packages, including ERP and MRP systems.