FDA guidance validates approach to data exchange in serialisation challenge

Adents is revolutionising the thinking about existing and pending global traceability and serialisation regulations with its top-down corporate IT approach and emphasis on the importance of data exchange

Adents, the French software provider and its Adents Pharma Suite solution, are revolutionising the thinking about existing and pending global traceability and serialisation regulations with its top-down corporate IT approach and emphasis on the importance of data exchange.

The US FDA guidance in December 2014, which states that it will not take action against manufacturers, wholesale distributors or repackagers who do not provide or capture the product tracing information required by the DCSCA, prior to 1 May 20151, validates Adents’ position, stating: 'Some trading partners have expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the supply chain.'

Adents views serialisation as a corporate IT project and not limited to production machinery and equipment and says that companies need to consider data exchange as a fundamental issue.

'The most common mistake we see is companies thinking about which machines and components to install to manage serialisation before thinking about data exchange,' says Jean-Luc Lasne, International Business Development & Alliance Director. 'The real issue is how to handle huge volumes of data while allowing machines to run at full capacity with no decrease in production.'

Adents Pharma Suite, its global software solution, ensures that no critical data is stored on the line and all information is automatically backed up and saved on a site server supervising the whole serialisation process. This avoids both data loss in the case of a computer crash and production down-time during a software upgrade.

In addition, the Adents solution easily integrates with all existing ERP systems, and with standard printing and camera devices at line level. Adents Pharma Suite is set up to work with existing devices and therefore a single version runs worldwide regardless of the configuration and software customisation is never necessary, the company says.

'Adents has more than 20 years’ experience in traceability software solutions. Unlike some players in the market, we haven’t had to adapt our offer to the regulations,' explains Lasne. 'This gives us an added edge in understanding the challenge for companies and producing the necessary software solutions which integrate perfectly with all existing enterprise IT systems.'

Although there has been much discussion recently about the DSCSA, 2015 should also see the arrival of the Delegated Act mandated by the EU Falsified Medicines Directive 2011. Morten Sorensen, newly appointed Director of European Business Development and recently arrived from Rockwell Automation, emphasises Adents’ commitment to this key market. 'With more than 30 million counterfeit medicines seized by customs at EU borders over the last five years2, serialisation is a major issue for European pharmas and CMOs. Adents is gearing up to be increasingly present across the continent in 2015 to be closer to our customers.'

Adents will be showcasing its Adents Pharma Suite solution at Pharmapack Europe on 11-12 February (Stand 824) and presenting 'Co-ordinate your IT system with regulation deadlines, production and quality requirements' at the Serialization, Track and Trace Symposium on 11 February.

References

1. DSCSA Implementation: Product Tracing Requirements — Compliance Policy - Guidance for Industry – 23rd December 2014

2. European Commission Directorate-General for Taxation and Customs Union