ScienTek Software

ScienTek Software develops iStability® LIMS, a web-based Laboratory Information Management System designed specifically for pharmaceutical stability testing programs and stability study management. The software is built as a turn-key solution tailored to stability professionals, and can be installed on-site and made operational in less than a day, after which it can be accessed remotely through secure means.

iStability® LIMS is intended to reduce the administrative burden of managing stability testing programs, enabling users to prepare regulatory submissions, perform statistical data analysis, and work toward product approvals without relying on manual spreadsheet-based workflows.

Core Capabilities

• Manages pharmaceutical stability testing programs end-to-end as a dedicated LIMS solution
• Supports FDA/ICH recommended statistical analysis methods for stability data, included out of the box with no additional modules required
• Generates statistical reports that are designed to be understandable without requiring a dedicated statistician or custom programming
• Allows data to be entered once and used to produce multiple report types, eliminating the need to copy data between spreadsheets or documents
• Produces reports including Study Summaries, Stability Data Summaries, Certificates of Analysis, and additional report formats

Deployment and Implementation

• Installed at the customer's site, with deployment typically completed in under one day
• Accessible remotely via secure means following on-site installation
• Described as a turn-key system that does not require months of customisation, unlike many general-purpose LIMS platforms
• No need to hire programmers or statisticians to implement or operate the system

Reporting

• Single data entry supports generation of multiple report types without manual data transfer
• Report types include Study Summary, Stability Data Summary, and Certificate of Analysis, among others
• Statistical analysis reports are produced directly within the system and are designed for ease of interpretation

iStability® LIMS is developed and maintained by ScienTek Software, Inc., and is marketed specifically to stability professionals in the pharmaceutical industry seeking a purpose-built, rapidly deployable alternative to general LIMS platforms or manual spreadsheet-based processes.