• StabilityLink offers comprehensive view of stability management programs for pharmaceutical, biotechnology and consumer health industry

StabilityLink® is a turn-key and paperless system tailored to pharmaceutical and biotechnology stability testing programs. It provides seamless integration between various departments from the initiation to completion of stability studies. StabilityLink® is a comprehensive solution designed in accordance with 21 CFR Part 11 and ICH Q1A-Q1F which facilitates study design, protocol approval, study initiation, data review, trend analysis, stability report generation and approval, and regulatory submission. Customizable alert, pull scheduling, statistical analysis and system notifications allow increase productive of stability management operation.


21 CFR Part 11 Compliant

Part 11 compliant with comprehensive audit trail and electronic signatures. Users portfolio and activities are captured in system log for in-depth auditing by Quality

Pull Schedule and Automated Reminders

Email notifications of pull schedules and data entry records increase productivity. Create custom pull schedules and alerts to be complaint with regulatory requirement.

Built-in Document Management

All documents from inception to completion of stability programs are archived within the platform. Paperless system makes it easy to scale

Search Capabilities

Powerful search options within the platform make it convenient to look up studies and manage stability portfolio of marketed products.

Relational Database

Relational databases used to store all data to assure safety, consistency, and reliability. Data is encrypted with controlled access for enhanced security. A relational database paired with a web-based application provides a superior combination.

Alternate Product Specifications

Supports US, EU, JP, and Canadian commercialization concurrently and generation of reports under alternate test specifications can be managed easily.

Data Analysis

Expiry Dating Calculation

Shelf life prediction is done by calculating the expiry dating period using zero-, first-, or second-order kinetics and predict data for future pull points.

Statistical Data Analysis

Statistical analysis of stability data with validated analysis which supports FDA/ICH recommended analysis methods. Statistical analysis could be incorporated in final stability report.

Poolability Determination

ANCOVA analysis according to ICH Q1E is used to statistically compare data from multiple lots of same products to determine if they can be pooled together.


We provide a dedicated customer success manager to all of our business partners.

Contact us for one month risk free trial of StabilityLink.

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