Qualis Stability a complete validated stability study management system
Qualis STABILITY is a web based stability management system designed based on guidelines provided by the FDA/ICH. Designed to meet the regulated laboratory handling a wide range of products, dosage forms that are manufactured for various international markets that need to cater to variety of regulatory needs across the globe.
Introduction
Qualis STABILITY can be deployed and scaled up from a simple single user to multi-user environment system in
any windows environment. It is a simple yetsophisticated software which is user-friendly with a simple workflow
reducing the time and manpower spent on the stability study creation, approval and execution. It handles complete workflow of a typicalstability study planning, including protocols with appropriate storage conditions, pull time periods with appropriate teststo be performed at varioustime points, re- cording of day to day stability test data results and generating reports for stability studies.
Features
- A Web based stability management software that runs on any browser with a database for stability studies.
- A completely independent system that can manage stability protocols, conduct studies, maintain study conditions, chambers. inventory control for study sample consumption, sample registration, result recording,
review and approval and study reports - Works with MS-SQL Server or PostgreSQL database as backend
- Complete 21 CFR Part11 features with audit trail better compliance for regulated labs
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