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 …
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 …
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 …
Spin-off’s or start-up’s – especially within the medical device industry – can benefit from a standard set of QMS templates. These templates help to ensure a solid foundation upon which to base their quality management upon. QMS templates provide 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 …
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 …
The EU General Data Protection Regulation will become effective on the 25th of May 2018. As outlined below the Data Protection Officer (DPO) position will most likely be a part time position in small and medium size Pharmaceutical and Biotech Companies. The DPO position will not be in line with the company’s core capabilities and it could be difficult …