Stability studies are routine procedures performed on Pharmaceutical
and Biotech drug products, active ingredients, media and excipients to understand
the long-term effects of the environment on the drugs and short term
accelerated tests under simulated environments. In these types of studies, the
product is analyzed at predetermined intervals for various parameters.
Caliber Stability module provides stability tests over varying periods
of time with varying intervals, as defined in the Stability Test Protocol. It
provides for Pre-Registration of Stability Test Protocol, Automatic statistical
Calculation of test results, Individual COA printing and one click graphical
representation of behavioral trend. It provides the controls and auditing for
compliance with regulatory requirements such as 21 CFR Part 11.