With about one year to go before U.S. deadlines begin phasing in, serialization continues to present challenges for pharmaceutical companies. “Time’s running out,” says Jim Cummings, vice president, Americas, for Adents. He spoke with PMP News at Pharma Expo, held November 6-9 in Chicago.
But rather than rush into any solution just to get started, pharma companies “should pay attention to what they’re getting,” Cummings advises. “Learn about the serialization requirements so you ask the right questions, and don’t just let a consultant point you toward a particular vendor.”
Cummings offers a list of key questions pharmaceutical companies should be asking their vendors before embarking investing in a particular solution:
- Can I use commercially available vision systems and other equipment?
- How long will it take to implement a solution?
- Will I need to shut down my line, and if so, for how long?
- If I need to make a software update, how long will it take?
- Can I aggregate with a particular solution?
- What is the total cost of ownership?
“Keep in mind that serialization is not just one project,” says Cummings. “There will be more products to serialize and more changes.”
He adds that serialization “should be simpler, much quicker, and with less total cost.” Adents works to minimize costs by being “equipment agnostic,” he adds. Its software is 100% configurable, and packaging lines do not need to be shut down to configure them—changes are made to the company’s site server, he explains.
The only time lines need to be shut down is when packaging machinery HMIs need to be updated and tested, Cummings says.
Adents can generate serial numbers from its own site server and communicate with a company’s server; Adents can also store and report commissioned numbers.
Adents recently partnered with Micorsoft to jointly develop and commercialize a new Cloud platform named Adents Prodigi, which will be available in the first quarter of 2017. Adents Prodigi is a Level 4 traceability solution for centrally managing pharmaceutical regulatory requirements. The approach utilizes Microsoft Azure to enable pharma manufacturers to securely generate, exchange, and control huge amounts of serialization data. The platform also facilitates data analysis for real-time data visualization and analysis as well as OEE and productivity monitoring across production sites. “Our alliance with the leader of Business Intelligence will be a game changer on the global market for unit identification. Indeed, this will finally give the pharmaceutical industry the means to tap into the full potential of the wealth of information generated through serialization,” stated Christophe Devins, founder and CEO of Adents, in the release.
Adents Prodigi can also host business applications offered by third parties to fully exploit data stored on the platform, the release reports.
For more details, visit www.adents.com.