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 …
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 …
The EMA SPOR (ISO IDMP) Task Force is continuously working on implementing the ISO IDMP standard. According to the EMA Substance and products data management services page the following apply: Product and substance data preparatory phase is ongoing and started after the launch of the RMS and OMS in 2017 Next phase is the “Product …
With legislation dating back to January 2009, requirements for serialization and reporting in Brazil has been underway for a long time now. Those of us having worked with serialization for a while, may remember working feverishly in second half of 2015 to comply with an almost impossibly complex set of requirements. The goal at the …
Read moreSerialization in Brazil – this time it is for real.
When building, maintaining, or developing a QMS everybody is aware, that there need to be procedures, policies, and work instructions in place. But not that many thinks of them as them as processes. That is too bad, because that is what they really are. And there is time to spare to get them front and …
Read moreMedical Device: Quality Management System processes
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 …
The full implementation of the EU MDR (Medical Device Regulation) was recently postponed until 26-May 2021 and for any Medical Device company that wants to sell their products in the European Marketplace, they have to be compliant with MDR. So, now you have plenty of time to get fully compliant with MDR? Not really, I’m …
Read moreEU MDR postponed until 26 May 2021. Relax, plenty of time?
Spin-off’s or start-up’s – especially with in the medical device industry – can benefit from a standard set of QMS templates, to ensure a solid foundation to base their quality management in the company on. The QMS templates provides the necessary baseline of QMS documents for the busy entrepreneur, to comply with both internal as …
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 …
Read moreHandling sensitive patient data in the US – Guide to HIPAA Compliance
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 …
Read moreAre we all done with Serialization after the EU implementation?