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 ...

Specifications ensure drug substances/products meet acceptance criteria, forming a foundation for robust control strategies. Validated methods must be fit for purpose, with MODRs providing flexibility ...

LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques. However, ...

In-line UV spectroscopy allows real-time monitoring of cleaning processes, enhancing process control and compliance with Pharma 4.0 goals. The method provides continuous detection of residual cleaning ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

The devices around us that generate and store the energy that powers our electronics and propels our vehicles rely on intricate chemistry that often happens in tiny spaces. But those ...