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