Easily define and manage both normal and accelerated stability testing schedules tailored to different products and batches, ensuring consistent execution.
Stability Management Software | Spectrum QMS & LIMS
Stability Management Software: Future-Proof Your Product Lifecycle with Spectrum QMS
Stability management software automates ICH-compliant stability studies —protocol design, sample pull scheduling, shelf-life calculation, and trend analysis — replacing manual tracking and spreadsheets with a controlled, audit-ready system. Spectrum's stability module provides a rigorous, parametric framework for monitoring product behavior across multi-year cycles, ensuring the right data is always available to keep your regulatory compliance moving.
FDA 21 CFR Part 11 Compliant Architecture
Audit-ready compliance at all times
Maintain strict regulatory adherence with secured electronic signatures, unalterable audit trails, and SOP compliance built directly into the LIMS framework.
Comprehensive Life Cycle and Degradation Monitoring
Track products across all variables
Seamlessly monitor product behavior across different months, storage conditions, packaging types, and orientations to evaluate product integrity and ensure regulatory compliance.
Shelf-Life Calculation and Trend Analysis
Accurately predict product viability
Spectrum’s Stability performs automated shelf-life calculations on test results up to a specified month and provides detailed graphical presentations, enabling proactive quality control management.
More reasons to switch with Spectrum
Dynamic Testing Schedules
Parametric Flexibility
Adjust fluctuating testing requirements and define complex result calculation formulae (like RSD) according to corporate manuals without needing custom programming.
Multi-Tiered Control and Passing Limits
Maintain precise quality targets by tracking both passing specifications and control/quality limits to achieve total quality management.
Extensive Reporting Suite
Generate standard outputs like sample status, % degradation reports, annual summaries, and comparative statements to evaluate historical data and solve new problems.
Work List Assignment
Optimize lab resources by assigning scheduled tests to specific analysts with defined completion timelines, while tracking KPIs and team performance for better workload visibility.
Comprehensive Investigation Logs
Capture stability testing issues by packaging type, month, condition, and orientation, with QMS integration to link related deviations and change controls.
FAQ
Frequently Asked Questions
Spectrum Stability is a specialized module within our enterprise quality management software designed to monitor product behavior during its complete life cycle. It tracks data across various storage conditions, months, and packaging types.
Yes, the Spectrum’s QMS is fully OSHA, ICHS, GMP, PIC/S, MHRA, and also FDA 21 CFR Part 11, 21 CFR Part 820, and 40 CFR Part 11, compliant. It features secured electronic audit trails that record original settings, new settings, initiators, and timestamps.
Spectrum’s QMS performs robust shelf life calculations on batch test results up to specified months. It then provides graphical presentations of shelf life alongside detailed calculation reports.
Yes, Spectrum’s stability module is an integral part of the broader Spectrum LIMS and quality control management software ecosystem, seamlessly maintaining real-time data to support total quality management across the lab.
Absolutely, users can define simple to complex formulas, such as Relative Standard Deviation (RSD), as well as both non-numeric text and numeric limits according to their specific corporate procedures.
Yes. Spectrum's stability management software supports protocol design aligned with ICH Q1A (long-term and accelerated stability testing), ICH Q1B (photostability), and ICH Q1E (bracketing and matrixing), alongside FDA 21 CFR Part 11 compliance.
Stability management software automates the scheduling, sample tracking, and shelf-life analysis required for ICH-compliant stability studies — replacing manual protocols and spreadsheets with a controlled, audit-ready workflow.
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Testimonials
What They Say About Us
A reliable partner for smarter laboratory management.
Working with Sofcom has been a rewarding experience. Spectrum has proven to be a valuable solution for managing laboratory operations, helping us improve data analysis and support better decision-making.
I look forward to Sofcom’s continued innovation and the positive impact their solutions will have on the pharmaceutical industry.
