A single point of truth (SPOT) for data or document management is a must in highly […]
Why you should rely on a central data management system for UDI-MDR
20 terms about MDR/UDI you should know
There is not much time left for MedTech industry to implement the regulatory requirements of the Medical Device Regulation (MRD). […]
Why serialization is now also a topic for OTC manufacturers
Pharmaceutical companies specializing in the production of over-the-counter drugs have not been affected by pharmaceutical serialization so far. […]
Along with the MDR comes the UDI – What does this mean for the MedTech industry?
The Medical Device Regulation (MDR) is an EU directive that will come into force on 26 May 2020 and represents a further large-scale revolution in industry. In addition to some reclassifications and high demands on data management, Unique Device Identifiers (UDI) on medical devices will also become mandatory. UDI labelling was introduced in the USA […]
Crypto-code and language barriers: Serialization in Russia and China
The implementation of EU-FMD is not the only track&trace initiative to protect against counterfeit medicines. […]
It doesn’t always have to be the big ones – why it is worthwhile for mid-sized companies to fall back on smaller software providers
If you think of business software, the well-known names of large software manufacturers come to mind […]
Serialization for pharmacies – what changes in everyday life?
In pharmacies hundreds of medicines are sold everyday. From 9 February 2019, all prescription drugs must be serialized. So what does the Falsified Medicines Directive (FMD) mean for pharmacies and their internal processes? Pharmacies usually purchase their medicines from wholesalers, where individual packagings can be checked optional. In the pharmacy every single medicine pack is […]
Serialization for hospitals – what changes in everyday life?
Hospitals work with a large number of Rx drugs on a daily basis, in addition processes are closely timed. So how will the Falsified Medicines Directive affect hospital pharmacies? The Falsified Medicines Directive (FMD) stipulates that every prescription-only drug in hospital pharmacies must be scanned and verified via the database. The Bundesverband Deutscher Krankenhausapotheken (ADKA), […]
Is the pharmaceutical industry a role model for other industries?
Traceability and a transparent supply chain play a key role in many industries. The key questions amongst all are the provenance and pedigree of a product as well as providing a secure and traceable path from the producer to the consumer. The pharmaceutical industry tries to summarize these questions under the keyword “serialization”. In the […]
What are the benefits of serialization?
The primary objective of serialization is to protect patients. This is ensured by processes and control mechanisms that ensure that only original and manufacturer-approved drugs reach pharmacies and hospitals. Sustainable changes in almost all areas Manufacturers, contract manufacturers, wholesalers, repackagers, parallel importers – or in other words: the entire pharmaceutical industry need to invest in […]