Zenith Technologies leads the field in fight against counterfeit drugs
Posted on October 7, 2016 by
Article Source: Irish Business Post
Cork-based Zenith Technologies has implemented one of the largest worldwide serialization projects ever for licensed drug products, aimed at protecting against counterfeit drugs and improving traceability in the supply chain.
The unique product identifier project, spanning over 200 product lines, across 20 sites, and 12 countries, was rolled out for one of the world’s top ten multi-national pharmaceutical companies.
The project was executed from Cork, Ireland, with support from global offices based in the UK, USA and India.
And the system, which helps its clients to meet the impending regulatory requirements of serialization, was delivered “against the clock” to ensure minimal downtime.
Pharmaceutical manufacturers in the EU are currently faced with the challenge of complying with new regulations for the serialization of licensed drug products from early 2019.
Zenith Technologies chief executive, Joe Haugh said the implementation of serialization presents a considerable challenge to pharmaceutical manufacturers in terms of modifying or replacing existing equipment with minimum production downtime to satisfy compliance requirements.
“Our serialization project is unique, highly complex and of great benefit to our customers and, of course, consumers. The new serialization rules for licensed drug products will ensure that people get correct medicines and not questionable counterfeit products that may not contain the required ingredients.”
Right: David Sheedy, Karolyn Murphy, James Nation, Grainne Lynch, Brian Quigley, David Powell ( not present in photo) Zenith Technologies serialization deployment team >>
“Deploying this software for our biggest client around the world in so many facilities, involving so many different nationalities and cultures, and against the clock, was a remarkable achievement for the dedicated team of engineers involved. I congratulate them for their creativity and innovation and their enthusiasm, hard work and highly professional service to our customers. They are a highly talented and brilliant team,” he said, adding: “ we are always on the look out for talented engineers to join our growing teams.”
Products manager and team leader for the IT section of the project, Cork-based, David Sheedy said the project was “pretty unique and complex. It was also a first as the regulations are new.
“From 2017 no pharmaceutical products can be sold in the United States without a unique 13 character serial identifier. That means a different serial number for every one of the millions of boxes sold every year,” he said.
“We were involved in system design, implementation and support. Equipped with laptops provided by our client and able to login to the company’s internal systems, our dedicated team was able to perform approximately 85% of the implementation work remotely, and this delivered further significant efficiencies.
“The same Zenith team that delivered implementation of the system is also managing software upgrades and providing 24/7 support for all client sites. This helps to ensure a fast and effective response by the people best placed to deliver the right solutions to any issues – the experts who created the templates and took the new systems through the processes of implementation, testing, validation and qualification”, said David.
Zenith Technologies operates 100% in the life sciences sector, delivering manufacturing software systems that make businesses compliant and competitive. The company specialises in manufacturing execution system (MES), automation and process control solutions that manage and control manufacturing plants to improve operational effectiveness.
Operating across five continents, Zenith’s engineers and consultants are guiding and supporting life science clients across the globe with the integration of the latest technologies, as well as delivering on-going local level technical support. Founded in 1998 by Brendan O’Regan (now executive chairman) and headquartered in Cork, Ireland, Zenith has 16 offices worldwide with nearly 700 people, delivering $75 million in revenue.
Zenith works with nine out of the top ten pharmaceutical and biotech companies globally and has been shortlisted for the Pharma Supplier of the Year Award, which will be announced in Dublin next Thursday (October 13)