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Caliber Stability


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.

 


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