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 ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

Confidence that your autoclave is sterilising effectively is essential, as there is no such thing as partial sterilisation. Ensuring your autoclave is performing correctly can be achieved in a ...

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, ...

Single-use bioreactors have been successfully implemented by the biopharmaceutical industry up to the 2,000-L scale. The performance of single-use bioreactors is comparable if not superior to ...