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Data and Analytics... a comprehensive cloud solution for managing STABILITY PROGRAM

A cloud based fully compliant FDA/ICH comprehensive tool for building, scheduling, and maintaining stability programs for manufactured and development of products. Through protocols configurations it successfully manages complex studies with multiple storage conditions, packaging types, and batches. The Stability Analytics solution 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.

A Web-based Stabi-M, Stability Studies Detailed Functions include steps of stability workflows in a simple layout, properties include schedules, specifications, time-points definitions and the general workflow of the stability sample execution. Permissions and workflow actions can be set up to match the business rules of the organization. All changes and edits are fully audited from the initial definition and saved through the approval, activation, use and final closure/archiving of the study. Key functional capabilities are:

Stability study and protocol execution (schedules, workflows) Stability specifications and business rules Stability sample management Stability testing/result entry Data review and reporting Stability chambers and inventory management

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