In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...

Biopharma manufacturers who want to validate their cloud-based biomanufacturing systems can’t apply the same processes to the cloud that they apply to their on-premises computer systems. Cloud ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug Administration ...