Linking Design Controls and Risk Management in the QMS
Design controls are a frequent citation in 483 observations and warning letters [...]
Design controls are a frequent citation in 483 observations and warning letters [...]
Documentation is a subject that comes up frequently in U.S. Food and Drug Admini [...]
Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufac [...]
Corrective and preventive action (CAPA) is a core function in any quality manage [...]
Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]
Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]
RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality mana [...]
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. [...]
The global pandemic brought an unexpected change – FDA remote regulatory assess [...]