StabLIMS™
Innovative Solution for Pharmaceutical Stability Laboratories.
Stability Laboratory Information Solution
STABLIMS™ supports all types of stability studies which includes most recognized climatic zones. Incubation temperature and relative humidity are the essential requirements of most studies; moreover frequency of testing and acceptance pulling days should be determined to automate the workload.
Determination testing intervals and infrastructure of inventory design including sample location are key features of the system.
Upgrade Your Lab with Elegant Solutions
STABLIMS™ aims to manage the day to day activities of stability department either in quality, research and development boards. The integrated system complies with current medicinal product regulations; FDA, WHO, CDER, ICH, ISO and CFR 21 Part 11 to manage and automate all types of drug products.
STABLIMS™ offers electronic worksheets that result in faster data entry, improve efficiency and reduce manual error. You have the advantage of complete tracking without ever having to print out anything. Our software meets up to 95% of customer requirements while still allowing the remaining 5% to be tailored to fulfill unique needs.
CORPEX StabLIMS — Frequently Asked Questions
What is StabLIMS stability management software?
CORPEX StabLIMS is a dedicated system for running pharmaceutical stability programs. It schedules and tracks every ICH Q1A pull point, links environmental chamber data to the affected samples, captures stability-indicating results with a full audit trail, and produces the statistical shelf-life evaluation and CTD Module 3.2.P.8 outputs needed for submission.
Which ICH conditions does StabLIMS track?
StabLIMS models ICH Q1A(R2) storage conditions — long-term 25°C/60% RH (or 30°C/65% RH) for at least 12 months, intermediate 30°C/65% RH, and accelerated 40°C/75% RH for at least 6 months — and lets you configure conditions per climatic zone, which matters for Egypt and the MENA region's hotter zones.
Does StabLIMS monitor environmental chambers?
Yes. StabLIMS logs chamber temperature and humidity against time and ties each reading to the studies inside. When an excursion occurs it immediately identifies every affected study and sample and triggers the appropriate deviation.
Is StabLIMS compliant with 21 CFR Part 11 and EDA requirements?
Yes. StabLIMS provides electronic signatures, a tamper-evident audit trail and ALCOA+ data-integrity controls that satisfy FDA 21 CFR Part 11 and map directly to Egyptian Drug Authority and EGAC ISO/IEC 17025 expectations.
Is StabLIMS suitable for Egyptian pharmaceutical labs?
Yes. As a CORPEX product it ships with Arabic and English support, on-site implementation across Egypt, and pricing in Egyptian pounds. See our LIMS for Egyptian laboratories page for how it fits local EDA and EGAC requirements.
Ready to Automate your Stability Studies?
Contact us today to learn more about how StabLIMS can streamline your operations.
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