Understanding ALCOA+ Principles and Data Integrity for Pharma
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]
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 [...]
Companies marketing devices in the European Union are facing a perfect storm of [...]
From Listeria in ice cream to E. coli in lettuce, there’s one central question i [...]
Software validation is historically one of the most difficult compliance activit [...]
As innovation in medical technology increases, potential cybersecurity threats a [...]
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
In the life science industry, adjustments are a necessary element throughout the [...]