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Dr. Thaleia Papadopoulou
By Dr. Thaleia Papadopoulou on March 22, 2022

In a constantly changing world that is dominated by uncertainty, many industries have already adopted Agile software practices, aiming at enhancing flexibility within their business processes and enabling innovation. Although the medical device sector has already embraced Agile within their systems and business organization, the pharmaceutical industry is lagging behind, mostly due to compliance concerns as well as misconceptions regarding regulatory expectations in a GxP environment.

Dr. Thaleia Papadopoulou
By Dr. Thaleia Papadopoulou
on October 13, 2021

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.

Dr. Thaleia Papadopoulou
By Dr. Thaleia Papadopoulou
on September 27, 2021

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.

Dr. Ulrich Köllisch
By Dr. Ulrich Köllisch
on August 27, 2021

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.

Thomas Cullum
By Thomas Cullum
on August 02, 2021

Let's discuss in this article the potential use of statistical analysis to accomplish a computer system validation.