Missed Sample Pulls
Manual calendars and reminders increase the risk of late pulls and incomplete study execution.
Advanced Stability Management
ICH-compliant stability testing software for pharma and biotech
TeraCliq Stability Management helps quality and laboratory teams manage the full stability study lifecycle from protocol design and sample pull scheduling to chamber monitoring, degradation analysis, expiry determination, and submission-ready reporting.
40%Faster shelf-life determination
ZeroMissed sample pulls
ICH Q1AAligned workflows
24x7Chamber monitoring visibility
Why Legacy Stability Programs Struggle
Manual stability tracking creates avoidable risk
Stability studies are often split across spreadsheets, paper logs, chamber systems, and laboratory workflows, making timing, traceability, and expiry decisions harder than they should be.
Weak Chamber Traceability
Storage conditions, excursions, and chamber occupancy are often disconnected from study records and results.
Slow Trend Review
Analysts still compile degradation trends and expiry assessments manually across multiple datasets.
Submission Burden
Preparing stability evidence for filings and inspections takes too much effort when data is fragmented.
Core Capabilities
Manage the full stability study lifecycle in one system
Stability Protocol Creation
Define ICH-compliant study designs, storage conditions, acceptance criteria, and sampling schedules with governed templates.
Sample Pull Scheduling
Automate pull planning, reminders, escalation, and rescheduling with a clean audit trail.
Chamber and Environmental Monitoring
Track chamber occupancy, temperature, humidity, and excursions alongside active study records.
Test Execution and Data Capture
Manage sample testing, result entry, calculations, and data traceability from study to analytical output.
Trend Analysis and Reporting
Use trend visualizations, degradation analysis, and reporting views for faster review and decision-making.
Expiry and Retest Decisions
Support expiry determination, retest date logic, and product shelf-life evaluation with evidence-backed workflows.
Study Workflow
From protocol setup to ongoing stability commitments
Design Protocol
Configure study matrix, storage conditions, pull points, and acceptance criteria.
Assign Samples
Map products, batches, and sample quantities to each study and chamber plan.
Monitor Storage
Track chamber conditions, occupancy, and any environmental excursions in context.
Execute Testing
Perform analytical testing at scheduled pull points with complete result traceability.
Analyze Trends
Review degradation patterns, historical consistency, and expiry risk indicators.
Report and Decide
Generate review-ready outputs for shelf-life, retest, and submission support.
AI-Powered Analytics
Faster shelf-life and expiry intelligence
AI Shelf-Life Projection
Project expiry windows earlier using trend-driven interpretation and confidence-based analysis support.
Early Risk Alerts
Identify potential degradation or stability drift before formal review milestones are missed.
Expiry Determination Support
Translate study data into evidence-backed expiry and retest decisions with better consistency.
Submission-Ready Output
Assemble stability evidence faster for internal review, annual commitments, and regulatory submissions.
Regulatory Alignment
Built for ICH, FDA, and GMP stability program expectations
ICH Q1A-Q1F Coverage
Structure studies around key global stability guidance with configurable protocol patterns.
FDA Stability Readiness
Support stability requirements, traceability, and evidence generation for regulated filings and inspections.
Ongoing Stability Commitments
Manage post-approval and annual stability obligations with planned, visible schedules.
Audit Trail and E-Signatures
Maintain complete electronic record visibility from protocol revision through result review and approval.
Integrated Digital GxP Ecosystem
Connect stability studies with the rest of your quality and lab stack
LIMS
Link sample testing, instrument outputs, and analytical results directly to stability studies.
eQMS
Send excursions, outliers, or abnormal stability events into formal deviation and CAPA workflows.
DMS
Control stability protocols, methods, reports, and approval documentation in one ecosystem.
APQR
Feed stability commitments and trend evidence into annual product quality review outputs.
ERP / Regulatory Systems
Share product master data, market requirements, and expiry decisions where needed.
Business Outcomes
What teams gain with advanced stability management
Faster Shelf-Life Determination
Reduce manual analysis effort and accelerate review-ready expiry decisions.
Missed Pull Reduction
Automated scheduling and reminders reduce execution gaps across ongoing studies.
Storage Visibility
See chamber conditions, occupancy, and excursion context without disconnected tracking.
Submission Confidence
Prepare more complete, traceable stability evidence for internal and regulatory review.
Stability Intelligence
Bring stability protocol management, chamber control, and shelf-life analytics into one platform
TeraCliq Stability Management helps pharma and biotech teams execute cleaner studies, reduce operational risk, and improve confidence in expiry and retest decisions.