Stability Management The stability management module provides full functionality for designing and performing stability programs to determine shelf life and potency degradation. lt can be implemented for production or research and development stability programs. Stability Protocol Definition INQAS provides full functionality to define the protocol for the stability program. The number of stability study stations and their respective time intervals can be defined. For each stability station, the number of samples from each storage condition and the test methods for each sample can also be predetermined. Stability Program Studies INQAS provides a stability plan that allows the stability program coordinator to distribute the stability workload throughout the year and assures that the minimum number of batches are placed in the stability program. Batches specified by the stability plan are automatically sampled. Enough samples are selected of each of the specified storing environments to support the stability program study. When stability samples are due for analysis, INQAS automatically requests the samples to be retrieved from their storage condition and sent to their respective laboratories. lt also specifies the test methods to be used to analyze each sample. The testing protocol can be modified during the stability study. INQAS provides time-phased stability reports that comply with regulatory bodies such as the U.S. Food and Drug Administration and may be displayed using a standard word processing software. Stability Reports A look-ahead report anticipates the retrieval of stability samples from storage. Stability reports are available to be downloaded to an Excel spreadsheet.