We smooth out your road to drug serialization compliance
Drug serialization is becoming a major challenge for the pharmaceutical industry as regulations are or will soon be in place in more than 40 countries. The deadlines for compliance with the Drug Supply Chain Security Act (DSCSA) in the United States or the Falsified Medicines Directive 2011/62/EU (EU-FMD) in Europe are fast approaching. Whether you are a pharma company, a contract manufacturer (CMO) or contract packager (CPO), you will need to have a serialization and track & trace solution up and running by 2017 or 2019 for the US and the EU respectively.
By the end of the decade, 80% of global drug supply will be serialized. Thousands of sites and packaging lines will be impacted by legal and regulatory requirements. With fast approaching deadlines and to avoid to put your business at risk, you will need a serialization solution that is quickly and easily deployable at your sites and works seamlessly with your existing line equipment and your enterprise information systems.
Legal requirements for the serialization of pharmaceutical products can differ vastly from one country to another in terms of scope, coding format, incident reporting, data storage and exchange etc. they can change without notice. To be compliant with a range of different rules and regulations, you need a solution that is fully configurable, highly flexible and adaptable to the ever-changing legal landscape surrounding drugs and medicines.
Implementing new industrial processes across production plants and lines is always a delicate operation that can make lengthy change control necessary. To minimize downtimes, you need a centralized configuration and process management software at site level that also enables you to keep up-to-date with changing regulations easily and to ensure fast and seamless changeovers for all your packaging lines without compromising Overall Equipment Efficiency (OEE).
Calculating the costs of serialization requires a holistic examination of the multiple elements impacting your implementation strategy. To avoid hidden costs related to software/hardware incompatibilities and change management, you need a standardized and highly scalable software solution deployed by a reliable and qualified system integrator.
your fast track to compliance
The road to serialization now has a passing lane: a turnkey solution combining a premium-performance software, a large choice of hardware and access to a global network of certified solution partners enabling you to easily and quickly address current and future regulatory requirements.
Benefit from Adents’ worldwide network of qualified machine builders and device partners. They offer a wide range of machines from simple Mark & Verify solutions to complex aggregation hardware to ensure smooth integration no matter the scope of your project.LEARN MORE
Together, Adents Seriza and Adents Prodigi provide you with everything you need to gain speed to compliance, support your Track-and-trace strategy while keeping overall equipment efficiency and minimize the risk of productivity drops. With Adents, transform regulatory obligations into opportunities.DISCOVER OUR SOFTWARE
Our global network of experienced system integrators delivers turnkey solutions and ensures your serialization solution is deployed timely and efficiently no matter the number of packaging lines to be equipped. They are reliably by your side throughout the whole process with highest standards of service and expertise.FIND A PARTNER
OPERATIONAL UP TO 5X FASTER THAN OTHER SOLUTIONS
WITH CURRENT LAWS AND SCALABLE FOR FUTURE LEGISLATION
SMOOTH ROLL-OUT AND OPTIMIZED SET-UP COSTS
TEAMING UP WITH INDUSTRY LEADERS
Our collaboration with Siemens provides drug manufacturers with Siemens’ range of powerful and reliable standard equipment incl. Adents’ premium-performance serialization software.
Learn more on Pharmaceutical Serialization
US-based CMO: Implementing drug serialization in 5 days to meet DSCSA 2017 requirements Check how Adents saved a New York state based Contract Manufacturing Company 3 weeks of downtime!
Implementing serialization & aggregation for a top European CMO: A case study This case study examines implementation of drug serialization and aggregation for a top leading European CMO on 4 sites, 7 lines to address 4 different export markets.
DSCSA - The Final Countdown If you cater for the American market, you need to start putting together a serialization implementation strategy now if you want to be compliant and operational in time with the DSCSA requirements.