STABILITY SYSTEM II by ScienTek Software, Inc. is a specialized solution for planning, executing, and documenting stability studies in pharmaceutical, biotechnology, and personal care environments. It consolidates protocols, sample inventory, storage conditions, pull schedules, and analytical results into a single, audit-ready system designed to support ICH guidelines and FDA expectations. The application helps QA/QC and R&D teams streamline workflows, maintain data integrity, and make informed shelf-life decisions with traceable, defensible records.
Key capabilities:
- Protocol management with version control, standardized conditions, and customizable study designs
- Automated pull scheduling with calendars, notifications, and workload visibility
- Environmental chamber management, including conditions, capacity tracking, and excursion documentation
- Sample and lot tracking, inventory control, barcode-enabled labeling, and chain-of-custody
- Data capture and trending tools for results evaluation and shelf-life assessment
- Comprehensive reporting (e.g., study summaries, trend charts, stability time-point reports)
- Security and compliance features such as role-based access, audit trails, and support for 21 CFR Part 11 controls, including electronic signatures
- Integration options to exchange data with instruments, LIMS/ELN, or enterprise systems
- Validation support materials to facilitate IQ/OQ/PQ and ongoing system maintenance
- Centralized deployment to align with corporate IT standards and multi-site operations
Benefits:
- Replaces spreadsheets and manual tracking with a controlled, validated environment
- Improves compliance readiness with complete traceability and auditability
- Reduces scheduling errors and missed pulls through automation and alerts
- Speeds decision-making with real-time visibility into study status and trends
- Enhances data integrity and transparency across QA/QC and R&D teams
STABILITY SYSTEM II provides a robust, purpose-built foundation for compliant stability program management, enabling consistent execution, clear documentation, and confident regulatory submissions.
STABILITY SYSTEM II is developed by ScienTek Software, Inc.. The most popular version of this product among our users is 2.0. The name of the program executable file is MKT.exe.
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