After defining which business processes are cGxP relevant the next phase is to map them in detail. The following steps are performed: A. Identify the systems (both paper and electronic) involved in the processing of cGxP data B. Define individual cGxP data elements C. Identify cGxP data elements that can be modified, deleted, or…
When assessing data integrity risks within an organisation, companies may focus immediately on those systems or areas that are the most obvious in this context, such as a particular software, a specific lab system or instrument etc. Doing so creates the risk of forgetting less visible but still important areas, processes or systems, or…
Let’s exploring the Topics in GxP Compliance within the PharmaceuticalIndustry. 1. Good Manufacturing Practice (GMP) GMP ensures that pharmaceutical products are consistently produced and controlled according to quality standards. This includes guidelines for facilities, equipment, personnel, documentation, and processes. 2. Good Laboratory Practice (GLP) GLP ensures the reliability and integrity of non-clinical laboratory…
