In the medical field, names and terms can be a bit overwhelming, from elaborate pharmaceutical names to medical diagnoses. Medical labeling is almost as complicated, so Loftware has put together an A-to-Z glossary for medical labeling.
“The world of regulated label management has its share of highly specialized and technical language.” This article provides links to additional information and understanding more about these terms enables you to stay informed about changes that occur in the medical industry.
Some of the key terms are:
AIDC (Automatic Identification Data Capture): refers to the method of automatically identifying an object, collecting data on it, and entering the information into computer systems, without any human involvement. A common example of this is a barcode.
Annex VI: A European guidance system for electronic records and electronic signatures in the pharmaceutical industry and is equivalent to the USA’s FDA 21 CFR part 11.
Artwork Management solution: A system used for label and packaging artwork design and layout. It is usually made up of illustration, page layout, image manipulation, and PDF editing software.
Cloud labeling solution: A cloud-based/SaaS labeling solution (rather than on-premise), gives companies more flexibility over how they manage the labeling and content management process. Cloud-based labeling solutions are available for businesses large and small.
EU MDR: The EU Medical Devices Regulation (EU MDR) was first introduced in May 2021, with some major implications for medical device labeling that will extend over the next 5-year period.
GS1: The international organization that oversees a system of globally recognized open standards for unique identifiers, such as barcodes that can be used throughout the supply chain to enhance traceability.
Any strong labeling solution can help take some of the complexity out of labeling. Whether it is a new start-up or an established business, having a strong foundation makes all the difference. Pragmatyxs can help take the guesswork out of choosing a solution that is best for you.