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Streamline Pharmaceutical
Stability Testing.

The industry-leading stability management software designed specifically for Pharma QC and Analytical Labs. Ensure uncompromising compliance, automate sample pull workflows, and accelerate time-to-market.

Built exclusively for modern Analytical Labs

Zentixs Stability streamlines the management of stability studies through centralized sample tracking, chamber monitoring, protocol management, and compliant analytical workflows for modern laboratories.

Built exclusively for modern Analytical Labs
Unified Platform Unified Platform

Centralize complaint intake, investigation workflows, CAPA tracking, and compliance reporting within a single connected platform.

Regulatory Compliance Regulatory Compliance

Ensure adherence to USFDA, EU GMP, and ICH guidelines with complete audit trails and standardized quality processes.

Lab-Centric Workflows Lab-Centric Workflows

Designed alongside QC scientists to align with real laboratory operations and modern analytical workflows.

Comprehensive Analytics Dashboard

Comprehensive Analytics Dashboard

Get a real-time bird's-eye view of all your stability studies. Track active protocols, withdrawals, and report statuses — so your team stays ahead of every deadline.

Live counts for active protocols, discontinued studies, and samples loaded
Upcoming withdrawal table with batch-level due dates at a glance
Withdrawal schedule status — pending, on time, overdue, and expired
Pending summary and approved report tracking with reviewer assignment
Chamber utilization trends across multiple storage conditions
Smart Report Generation

Smart Report Generation

Generate detailed stability summary reports effortlessly. A structured guided form ensures every report is complete, parameter-specific, and fully audit-ready.

Filter by product, customer, and site for pinpoint report accuracy
Protocol number and batch number selectors for granular scoping
Condition-based selection matching specific storage environments
One-click report generation once all parameters are configured
Seamlessly switch between Data, Summary, and Trend Analysis tabs
Trend Analysis & Boundary Monitoring

Trend Analysis & Boundary Monitoring

Monitor stability trends against defined temperature and humidity conditions using interactive line charts. Instantly spot deviations from acceptance limits before they become compliance issues.

Line charts plotting measured values against defined acceptance limits
Labeled chart variant for quick identification of data points over time
Batch-wise and time-point filters to drill into specific study segments
Visual boundary lines for 30°C ± 2°C / 35% RH ± 5% thresholds
Export chart images directly from the trend analysis view

Comprehensive Stability Management

Everything your lab needs to manage the entire lifecycle of a stability study, from initial protocol drafting to final statistical trending and reporting.

Protocol Management
Protocol Management

Easily create, review, and approve complex stability protocols. Support for bracketing, matrixing, and custom testing intervals across multiple storage conditions.

Chamber Inventory
Chamber Inventory

Visualize and manage storage space across all climatic chambers. Track temperature and humidity deviations with automated alerts linked directly to studies.

Automated Pull Schedules
Automated Pull Schedules

Never miss a time point. The system automatically generates comprehensive pull schedules, triggering notifications and assigning tasks to available lab personnel.

Statistical Trending
Statistical Trending

Built-in statistical tools for degradation tracking and shelf-life prediction. Generate ICH-compliant regression plots without exporting data to external tools.

LIMS & ERP Integration
LIMS & ERP Integration

Seamless bi-directional connectivity with your existing Laboratory Information Management Systems and Enterprise Resource Planning software.

OOS / OOT Management
OOS / OOT Management

Instantly flag Out of Specification and Out of Trend results. Automatically initiate investigation workflows linking deviations to the original study.

Seamless Laboratory Workflow

A structured, guided process ensuring no critical steps are missed during the lifecycle of a stability study.

Seamless Laboratory Workflow
Initiate Study
Initiate Study

Draft protocol, define testing matrices, assign specifications, and route for digital QA approval.

Load Chambers
Load Chambers

Print compliant labels, scan barcodes, and allocate physical space within the stability chambers.

Pull & Test
Pull & Test

Receive automated alerts for timepoints. Pull samples, execute analytical testing, and input results.

Analyze & Report
Analyze & Report

Review statistical trends, generate comprehensive final reports, and finalize shelf-life conclusions.

Regulatory Compliance

Uncompromising Regulatory Compliance

Built from the ground up to satisfy the most stringent requirements of global regulatory bodies including the FDA, EMA, and MHRA.

21 CFR Part 11
21 CFR Part 11

Full support for electronic signatures, secure user authentication, and strict access controls.

Comprehensive Audit Trails
Comprehensive Audit Trails

Immutable logging of who, what, when, and why for every action taken within the platform.

Data Integrity (ALCOA+)
Data Integrity (ALCOA+)

Ensuring all data remains Attributable, Legible, Contemporaneous, Original, and Accurate.

ICH Guidelines
ICH Guidelines

Out-of-the-box templates and statistical methods aligned with ICH Q1A(R2) through Q1F.

Frequently Asked Questions

Zentixs Stability is a stability management platform for Pharma QC and Analytical Labs, covering studies, samples, chambers, testing, trending, and reporting.

Automated schedules, reminders, task assignments, and status tracking keep every study aligned with its required testing intervals.

Yes. It automatically generates time-point schedules, sends alerts, and assigns pull tasks to help prevent missed stability intervals.

Yes. Track chamber inventory, storage conditions, utilization, and temperature or humidity deviations with study-linked monitoring.

Yes. Built-in statistical trending helps visualize degradation patterns, assess acceptance limits, and support shelf-life evaluation.

Yes. It supports bi-directional integration with existing LIMS and ERP systems to connect stability data with broader laboratory workflows.

Keep Your Business Ready for Action