Mini PCI express boards.

The CP-102N Mini PCI Express multiport serial board, from Moxa, is to fulfill the need for customized expansion of industrial automation systems, plus enables faster time to market for OEMs and integrators, with minimal increase in power consumption or system footprint.

Designed for industrial automation systems and industrial PC manufacturers, the CP-102N is compatible with any Mini PCI Express slot, and requires only a 3.3 VDC power supply, allowing it to work with host computers ranging from DIN-rail PCs to standard-sized PCs. It includes isolated and non-Isolated RS-232/422/485 communication cards for various applications, along with high-performance 16C950 compatible UARTs.

The CP-102N is a top choice for automation engineers and system integrators. In addition to supporting Windows and Linux operating systems, it features four RS-232 serial ports for faster, more reliable data transmission at baudrates up to 921.6 kbps. It also provides full modem control signals to ensure compatibility with various serial peripherals, plus offers 1 kV line-to-line surge protection and 2.5 kV isolation, ensuring safe use in a wide range of industrial environments.

The industrial-grade CP-102N can operate in the -40 to 85˚C temperature range.

@MoxaInc @OConnellPR  #Automation #OEM

Research reveals barrier to serialisation compliance.

According to new industry research more than half (54%) of industry professionals believe that the cost of implementing serialization is the greatest hurdle to compliance.

The research, conducted by serialization software provider, SEA Vision and  Zenith Technologies, highlighted that the substantial investment required to implement a serialization solution is cause for concern ahead of regulatory deadlines in the US and Europe.

A further 33% of survey respondents stated the implementation process would be a drain on internal resource. Others (31%) cited tight timescales as a pain point, a statistic that is further supported by the announcement that the FDA will delay the active enforcement of the Drug Supply Chain and Security Act (DSCSA) due to a lack of readiness across the industry.

Commenting on the research, Carlos Machado, serialization director at SEA Vision US said: “The new regulations in the EU and the US represent a substantial upfront investment for companies across the supply chain and many smaller players are struggling to implement a suitable process as a result.

“The resource required in terms of cost and manpower is a notable barrier to compliance, but added to that, the time it takes to develop a solution has been gravely underestimated by a large part of the industry. Many (37%) of our survey respondents expressed concerns surrounding the potential disruption to product supply as a result of technical issues and downtime, which clearly demonstrates the impact serialization could have at an operational level.

Consolidation across the outsourcing space has been prevalent for some time now and serialization is undoubtedly driving smaller companies to consider partnerships to offset a lack of manpower and budget. However, 36% also believed that there was a knowledge gap in their existing teams surrounding serialization, making external expertise vital to ensuring compliance."

Machado continued: “With time and cost becoming a growing concern across the pharmaceutical industry, it’s no surprise that smaller partners, particularly contract manufacturers, are looking to consolidate to expand their internal resource.

“In addition to consolidation and a growing trend to outsource serialization requirements, it is also likely that we will see an increased reliance on third party implementation specialists with the knowledge and expertise to effectively introduce the necessary changes and also help companies realise the wider business benefits that can be achieved. For example, implementing serialization can also help to improve line performance and overall equipment effectiveness (OEE).”

In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialization across drug manufacturing sites.

The collaboration brings together Italian-based SEA Vision’s serialization system along with global Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.

 @ZT_Global  #PAuto #Pharma  @ramarketingpr

Major doubts revealed about requirements for serialization!

More than one third (40 per cent) of pharmaceutical industry professionals are not confident that they will meet serialization deadlines in the US and Europe, according to new industry research.

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As the FDA has announced plans to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) in the US to November 2018, the research, conducted by SEA Vision and  Zenith Technologies, gives further evidence for the need for additional time both in the US and Europe.

Just 18 per cent of those that took part in the survey are ‘extremely confident’ that they will meet impending track and trace deadlines, including the US DSCSA and the European Falsified Medicines Directive (FMD).

Highlighting a major cause of the lack of preparedness, 40 per cent of industry professionals admit that they are not clear what the global requirements for serialization are.

Despite the lack of understanding, the majority (38%) of companies will rely on an in-house team to handle the entire implementation. One third will use an implementation partner and 20 per cent will rely on their software and hardware providers for the required support and expertise.

Commenting on the research findings, Carlos Machado, serialization director at SEA Vision US, said: “Clearly the industry is going through a challenging period and there is nervousness around whether the supply chain will be ready for compliance deadlines in the US and Europe.

“The delay of the active enforcement of the DSCSA should not be viewed as a reason to be complacent, but instead the chance for small and mid-sized manufacturers that are behind in their serialization journey to get their preparations back on track.

“Just 43 per cent of those companies surveyed are already supplying serialized products to other markets where regulations are in place, so for many, the DSCSA and the FMD are steps into the unknown. As a result, we believe that reliance on implementation partners will increase and this brings about new challenges as demand may surpass capacity as the deadlines draw closer.”

• In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialization across drug manufacturing sites.

@SEA_Vision  @ZenithIre  #PAuto 

Dangerous underestimation of urgency in meeting drug regulations.

New industry research reveals that more than one third (36 per cent) of pharmaceutical manufacturers and contract packagers are not currently preparing for global serialization requirements, despite impending deadlines.

The research, conducted by serialization system provider SEA Vision and life science technology firm Zenith Technologies, highlights an urgent need for companies to turn their attention to meeting the demands of the US Drug Supply Chain Security Act (DSCSA) and the European Falsified Medicines Directive (FMD).

Out of those companies that are not preparing for the new regulations, around half (51 per cent) say it is because they don’t currently have enough internal resource to devote to serialization, while 15 per cent believe it is too early to begin preparations.

Commenting on the research, Carlos Machado, serialization director at SEA Vision US, said: “Our research has confirmed that many companies are under-estimating the enormity of the task at hand. Preparing for serialization is a complex process that is so much more than simply integrating new technology on a packaging line. Instead, it should be a company-wide initiative, involving all corners of an organisation and the wider pharmaceutical supply chain.

“Those companies that delay their preparations risk production downtime and loss of business in key markets.”

For 56 per cent of those that have begun their serialization journey, compliance is the only goal of their serialization project at this stage. Just 44 per cent intend to use the process to achieve wider business benefits.

Carlos continued: “While serialization presents a number of challenges, it also creates an opportunity to review business processes and improve productivity. Those companies that embrace the changes and make preparing for the DSCSA and the FMD a priority, have a real opportunity to differentiate their offering, and it is our goal to support this process.”

In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialization across drug manufacturing sites.

The collaboration brings together Italian-based SEA Vision’s serialization system along with global Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.

@SEA_Vision  @ZenithIre  #PAuto #Pharma

Serialisation research survey!

"What is the biggest challenge you face when preparing for pharmaceutical serialisation? Are you clear what the global requirements for serialization are?" asks Zenith Technologies.

Zenith along with with SEA Vision is conducting some serialisation research to better understand users' views.

Participants in this short serialisation research survey will gain exclusive access to a free e-book with tips and guidance to prepare for new serialisation regulations, while also helping to significant business improvements.

Participation in serialization research will ensure receiving a summary of the findings (though responses will of course remain anonymous).

 @ZenithIre  #PAuto @SEA_Vision

Global serialization partnership.

Zenith Technologies and SEA Vision have formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialization across drug manufacturing sites.

Jim Lehane, director of MES & NBI Zenith,  

Marco Baietti,  commercial director, & 

Stefano Cobelli, sales director, SEA Vision 

with Dominic Galvin, chief financial officer, 

Zenith.

The announcement comes after the two companies completed the worldwide implementation of a serialization deployment to aid the production, packaging and supply chain of one of the world’s top 10 pharmaceutical firms.

Initially encompassing the US, Britain, Ireland and Germany, markets where both companies have a strong presence, the collaboration brings together Italian-based SEA Vision’s serialization software along with global Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.

Jim Lehane, director at Zenith Technologies, said: “We are delighted to have secured the rights to distribute, implement and support SEA Vision’s serialization solution in these key territories.

“The partnership enables pharmaceutical manufacturing and packaging companies to utilise SEA Vision’s products with added on-the-ground assistance from our expert engineers to ensure they can deal with the continuous challenge that serialization brings.

“Given what we’ve already achieved to date in this field and the similarities in our customer base, we are ideally placed to work together with SEA Vision to help clients achieve seamless compliance with the new serialization requirements. We truly believe this is a turn-key solution for installation, integration and support for any company producing licensed products.”

The deal has been unveiled as drug makers begin to seriously turn their attention to the looming legislation changes. The serialization of licensed drug products will be legally required for companies in the EU from 2019 as per the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation and from November 2017 in accordance with the US Drug Supply Chain Security Act (DSCSA).

Marco Baietti, commercial director at SEA Vision, said: “As a business, we are 100% focused in the pharmaceutical space and are committed to helping companies deal with the challenge of serialization.

“Following the announcement of the timing for the legislation changes, we have experienced a wave of requests from tier two and three pharma companies. This collaboration is therefore designed to give these firms the tools and skills they require to confidently introduce new systems well ahead of the deadlines.

“We are known for our reliability, technical solutions and customer service. Combined with Zenith Technologies’ global reach and proven training expertise, we believe our partnership can benefit pharmaceutical manufacturing companies in all these territories.”

Aside from traditional pharmaceutical companies producing bulk API and finished licensed products, the partnership will also assist contract manufacturing organisations (CMOs) that also need to adapt to the regulations.

Headquartered in Cork and with 14 offices globally, Zenith Technologies is one of the leading companies in delivering manufacturing software systems that enable life science businesses to be compliant and competitive.

SEA Vision, located in Pavia, close to Milan, with subsidiaries in France, Spain and Brazil, was set up in 1995 as a producer of vision systems for the pharmaceutical industry, with the aim to meet control requirements on packaging lines. To date, the company has successfully supplied over 250 complete track and trace systems worldwide.

@ZenithIre #PHarma #Pauto