iStability LIMS

iStability LIMS is a web-based Laboratory Information Management System (LIMS) developed by ScienTek Software, designed specifically for pharmaceutical stability testing programs and stability study management. It is intended for stability professionals who need to manage testing schedules, enter study data, generate regulatory submissions, and perform statistical analysis without relying on spreadsheets or custom programming.

The system is delivered as a turn-key solution that can be installed on-site and made operational in less than a day. Once deployed, it can be accessed remotely through secure means, making it available to users regardless of location.

Core Capabilities

• Manages pharmaceutical stability testing programs end-to-end, covering study setup through data entry and reporting.
• Supports FDA/ICH recommended statistical analysis methods for stability data, included out of the box with no additional modules required.
• Generates multiple report types from a single data entry point, including Study Summaries, Stability Data Summaries, and Certificates of Analysis.
• Eliminates the need to copy data between spreadsheets or word processing documents by centralising all study data in one system.
• Produces reports designed to support regulatory authority submissions.

Statistical Data Analysis

• Implements FDA/ICH recommended analysis methods directly within the platform.
• Generates easy-to-understand statistical reports without requiring a statistician or custom programming work.
• All statistical functionality is included in the base system with no separate modules to purchase or configure.

Deployment and Setup

• Designed for rapid deployment — the system can be installed and operational in under one day, in contrast to conventional LIMS implementations that may take months or years.
• Tailored specifically to pharmaceutical stability testing, reducing the need for customisation before use.
• Accessible via web browser after installation, supporting remote access through secure connections.

iStability LIMS is developed and maintained by ScienTek Software, Inc. The platform is positioned for stability professionals in the pharmaceutical and life sciences industry who require a ready-to-use system for managing stability studies and producing compliant regulatory documentation.