Clinical Research Solutions
Life Sciences Data Analytics: The Importance of Big Data
Big data is hitting us from all angles, and life science industries are not being left out. Why? Your life depends on it, literally. Life sciences generate lots of large and complex data every single...
Clinical Research Solutions
Using a Matrix Approach to Media Fills in Sterile Compounding
Using a Matrix Approach to Media Fills in Sterile Compounding: A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to...
Clinical Research Solutions
Critical Components of Quality Management Systems
Critical Components of Quality Management Systems: In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP), which must be compliant...
Clinical Research Solutions
How to Write an Effective Quality Investigation Report
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
Clinical Research Solutions
Operational Qualifications 'Worst Case' Conditions
A common principle in Operational Qualification (OQ) studies is to challenge processes under worst case conditions. A "worst case" condition or set of conditions are generally those parameters...