The FDA’s mandate for Unique Device Identification (UDI) of medical devices aims to offer a practical solution which proposes a standard way of presenting standard information in a standard format or barcode. (more…)
Posts Tagged ‘FDA’
Mar 22nd
PRISYM Medica
PRISYM Medica is a purpose designed labeling software solution for Life Science organizations specifically developed to meet the FDA’s current 21 CFR Part 11 compliance requirements. PRISYM Medica is supplied as a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model. (more…)
Feb 1st
What is FDA
The Food and Drug Administration (FDA) governs health and human services in the United States. It protects public health by enforcing safety and security regulations for drugs, vaccines, and other biological products and medical equipment. (more…)
Nov 11th
What is 21 CFR Part 11 ?
PrisymID have been a leading supplier of labeling software solutions to the world’s Life Sciences companies for almost 25 years including over 10 years of experience delivering labeling solutions to meet the requirements of 21 CFR Part 11. (more…)
