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.

your challenges

1
deadline
DEADLINES

How can I keep tight regulatory deadlines?

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.

2
legal
COMPLIANCE

How do I remain flexible to adapt to evolving regulations?

3
graph
PRODUCTIVITY

How do I maintain my OEE?

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).

4
deadline
BUDGET

How can I keep control of the costs of serialization?

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.

5
legal
DATA MANAGEMENT

How can I address the challenges of serialization data management?

6
graph
BEYOND COMPLIANCE

How can I create value for my business out of the massive amount of serialization data?

Once the compliance objective fulfilled, Pharmaceutical companies and CMOs should be able to benefit from the massive amounts of data generated during the serialization and track & trace process. Future proof serialization and traceability solutions should open new horizons to create value beyond regulatory compliance, in terms of data analysis, machine learning tools, and additional capabilities through existing in-house or third-party solutions.

your
FAST TRACK
TO COMPLIANCE

Adents is the leading provider of end-to-end traceability solutions to secure local and global supply chains.

We help pharmaceutical companies, Contract Manufacturing Organizations (CMOs) and their Supply Chain Partners to adapt to market changes and comply with regulations on drug traceability with the only integrated serialization solution covering all track and Trace needs, seamlessly.

What do you
need to achieve ?

Centrally manage serialization requirements and data, connect with trading partners and leverage the power of my data

Identify and decommission serial numbers at various stages in the supply chain

Implement item-level serialization at a manufacturing site on one or multiple lines

Perform product verifications to reintroduce returned saleable units

key benefits

fast deployment

Operational up to 5X faster than other solutions

Timely compliance

With current laws and scalable for future legislation

Cost efficiency

Smooth roll-out and optimized set-up costs

big data ready

Securely leverage the business potential of your data with the latest technologies

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.
Together, we offer a data management software solution to comply with regulations and mine the massive amount of data derived from serialization.

LEARN MORE ON PHARMACEUTICAL SERIALIZATION

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.

 

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.

 

 

The Drug Supply Chain Security Act (DSCSA) will require many changes for your business and some of them will be highly complex. Change equates to risk. The greater the impact, the higher the level of risk.

 

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