Medical Device: 238 days!

238 days and counting down.  That’s the number of days before EU MDR goes into effect.   For many Medical Device companies this seems like very few days to get ready!   If you factor in weekends and holidays – it’s only about 170 days. This raises some key questions to consider: Do you have enough time …

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Why Devops and SAP ATTP should go hand in hand

Since 2016 all pharmaceutical companies have implemented solutions to support Serialisation requirements from different markets.  I have been involved in implementations at 3 different clients. The question i receive most often is how to transition from a successful implementation to a more stable operation of SAP ATTP, without keeping the project team around indefinitely. I …

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Serialisation: Handling EMVS alerts

For the past years we have been working with clients on their Serialisation compliance and with this post we want to share some of the insights gained while helping clients to find operational ways to handle the EMVS alerts. The challenges Authentication of FMD compliant packs against the EU hub became mandatory for dispensers with …

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Handling sensitive patient data in the US – Guide to HIPAA Compliance

In the following post Pharma IT will describe the content of the HIPAA legislation and give some points to what is important in respect to implementation of HIPAA compliance. Should you need assistance to establish HIPAA compliance in your organisation, please contact us HIPAA – the Health Insurance Portability and Accountability Act sets the standard …

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Are we all done with Serialization after the EU implementation?

FMD Implementation Most companies in the pharmaceutical sector have their eyes on EU and have full speed on their FMD implementation. Every week, good news and progress are announced from different partners in the Supply Chain, and more and more countries are getting their national systems connected to the central database EMVO. This is all …

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