User Community

"The implementation of the Analytical Target Profile (ATP) within the company involved several important aspects. Initially, the ATP served as a tool ...

"Robustness testing is a frequently debated topic, particularly regarding how and when it should be performed. Guidelines are often interpreted to mea...

"The statistical approach underlying an assay failure risk assessment can take many forms. Populating the various fields of an FMEA can be supported b...

"In my opinion, using trending data to complement—or even shorten—validation studies should not be an issue, provided it's done appropriately. The pri...