Authors: Chong Yang Gue and Dr. Thaleia Papadopoulou
If you missed How Pharmaceutical Companies Can Implement Agile Methodology Part 1 of 2 about how to successfully implement Agile in pharma, we suggest you start there to learn about general Agile development methodology and, specifically, how it can be incorporated in an Agile pharmaceutical development environment. In part 2 we look at the tests and approval approaches adopted in Agile applications within GxP scenarios.
Authors: Chong Yang Gue and Dr. Thaleia Papadopoulou
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 still behind, mostly due to compliance concerns and misconceptions regarding regulatory expectations in a GxP environment.
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.