In this 2nd part of the article series, we discuss the main outcomes in respect to eSource and EHRs in context with current regulations and expert views.
Global collaboration between regulatory agencies and health authorities became of paramount importance during the COVID-19 pandemic. Not only allowed it regulators to continue their inspections and surveillance function, but the cooperation also enabled the rapid development and approval of treatments and vaccines against the coronavirus SARS-CoV-2.
FDA recently published its quality report for FY 2020 which presents us a very interesting collection of observations, trends, and programs. Read more about it here.
Let's discuss in this article the potential use of statistical analysis to accomplish a computer system validation.
Regulatory bodies like the FDA enact initiatives on a routine basis. While their timing may seem random, such actions are usually driven by logic; most are taken in response to some noteworthy concern.