What is Stability Management Software?

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What is STABILITY management software?

 

Stability management software is designed to make chemists’ and scientists’ jobs easier by providing total management of drug products placed on stability. Products like H&A Scientific’s SLIM (Stability Lab Information Manager) software allow a company’s drug stability program to be managed with optimal efficiency. SLIM is a fully validated software system designed to be compliant with FDA GxP guidelines for software development and validation. It includes functionality for electronic records, event logs/audit trails, change controls, and electronic signatures rules of 21 CFR Part 11 related to “closed” systems.

Other features such as a workload calendar for scheduling stability pulls, inventory management, product data management, notifications for out-of-spec (OOS) results, late lists, etc. are critical to a stability team. It is also important to be able to generate regulatory submission reports and perform statistical shelf-life determination for complete management of a stability program.

Our suite of stability products can help you complete these tasks with ease!  Schedule a demo with us to see how.

STABILITY LABORATORY DATABASE MANAGER

Commercial off-the-shelf solution for complete management of your drug stability program.

INTUITIVE SHELF-LIFE PROJECTION SOFTWARE

Developed specifically to determine the shelf-life of drug products placed on stability.

VALIDATED & CUSTOMIZABLE REPORT GENERATION

Seamless generation of validated stability reports in a format ready for FDA submission.

DEDICATED TO CONTINUOUS IMPROVEMENT

Designed to maintain compliance with requirements of the FDA and GAMP.