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Serialization/Unique Device Identification

Highlights
What does FDA’s DSCSA enforcement delay really mean?
What does FDA’s DSCSA enforcement delay really mean?
Jul 26, 2017
FDA is delaying enforcement of the upcoming product identifier requirement under the Drug Supply Chain Security Act, but should this delay alter your plans?This past June, FDA announced that the agency “does not intend to take action against...
Serialization validation: Start early, says expert
Serialization validation: Start early, says expert
Jun 21, 2017
Validation is a critical step in implementing serialization programs. Planning your validation approach early on can help you establish your solution objectives and work toward minimal production downtime and cost, explains Vito Pirrera, executive...
5 ongoing challenges for UDI
5 ongoing challenges for UDI
May 23, 2017
Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI.“But UDI is not over,” says Ardi Batmanghelidj, President and CEO...
6 questions you should ask before choosing a serialization solution
6 questions you should ask before choosing a serialization solution
Nov 18, 2016
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...
Standardizing serialization data exchanges
Standardizing serialization data exchanges
Nov 04, 2016
The Open Serialization Communication Standard (Open-SCS) Group was founded last year to standardize packaging line serialization and aggregation data exchanges by developing a set of industry-wide standards. Vendors comprising the group include...
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