2019-04-18 | The PDSA's New DSCSA Governance Proposal Explained

On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...

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2019-01-07 | Systech UniSeries rises to the repackaging challenge

Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.

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2018-02-23 | The 2017 GS1 US Barcode Assessment

Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson.  The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.

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2017-11-10 | Europe's Readiness for the Falsified Medicines Directive is Lagging

 

GS1 Ireland and Enterprise System Partners (ESP) just published an interesting Serialization Industry Readiness Report 2017 .  The report is based on their survey of drug manufacturers, CMOs, virtual manufacturers and others who will fall under the European Union Falsified Medicines Directive (FMD) when it goes into effect on February 9, 2019.  The readiness survey was conducted between May and July 2017.
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2017-10-27 | GS1 Healthcare Conference Recap

 

Systech is a member and strong supporter of GS1 Healthcare, the global group that promotes standardization in healthcare product and entity identification.  On October 17, 2017 in Chicago, GS1 Healthcare held their fall Global Healthcare Conference.

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2017-04-21 | Our View: Strengthening Supply Chain through Standardization

 Pharmaceutical serialization has been around since 2005, with Systech being the first vendor to deliver a solution. The market has grown, and international standards are still varied and complex. Implementations and data constructs vary from vendor to vendor. These factors provide several challenges to businesses' supply chains.

 

 

Efforts are underway to help standardize.

On April 13, 2017, Automation World Senior Editor, Stephanie Neil wrote an article “Strengthening Supply Chain.”  This...

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2017-03-28 | Data Sharing Required by European Hub; Pharmacies to Verify Before Dispensing

Drug manufacturers who market drugs in Europe will need to begin applying unique identifiers and an anti-tampering device to their packaging by February 9, 2019. Most companies are already aware of these well-publicized requirements of the Falsified Medicines Directive (FMD) and the E.U. Delegated Regulation (EUDR). Systech offers packaging line management and serialization solutions that will allow you to easily meet these requirements. But you might not be aware of the other big...

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