Current Good Manufacturing Practice (cGMP) regulations require that companies maintain minimum standards for processes, equipment, facilities and quality management systems. However, it can be challenging to accurately record and track various data..
We all expect that the medicine we receive is safe and effective. For pharmaceutical products to meet these requirements, regulatory authorities, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), ensure..
Data integrity is not a new problem and continues to be the major focus in regulated cGMP laboratories worldwide due to data falsification, poor data management practices, or ignorance of the regulations. Several regulatory agencies such as the..