Stabi-M

Stability Studies Management software is fully complaint system for scheduling, and maintaining stability programs for manufactured products and product that are on research development, it manages complex studies with multiple storage conditions, packaging sizes, packing types, and orientations of batches. It provides a consistent toolset to standardize and perform required statistics throughout the stability program and supports the complete activities of highly regulated stability operations as outlined in ICH guidelines by automating the process of executing sample studies under various experimental conditions over an extended period of time. Stability data are critical to the product development and on-going quality control of products of various dosage forms. Stability studies data analysis form the foundation for specification limits, expiration dates and storage conditions and play an important role in managing continuous product and process improvements and in indicating product quality on a batch-to-batch, lot-to-lot basis.