Stability LIMS Software | ICH Q1A Stability Studies

Stability Management

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.

End-to-End Stability Study Management

Complete Stability Study Management, in One System

StabLIMS unifies the full stability study lifecycle — so a single stability LIMS software platform runs protocol design through shelf-life determination without spreadsheets or manual transcription.

Design

Stability Protocol Creation

Define studies, conditions, time points, tests and specifications from reusable protocol templates aligned to ICH Q1A.

Schedule

Sample Pull Scheduling

Automatic pull-point calendars and reminders for every interval, so no stability time point is ever missed.

Store

Chamber Storage Management

Track chamber inventory, capacity and location, with temperature/humidity logging tied to the studies inside.

Test

Test Execution & Data Capture

Electronic worksheets capture stability-indicating results directly, with a full ALCOA+ audit trail.

Analyse

Trend Analysis & Reporting

Statistical trending across time points and conditions, with excursion detection and inspection-ready reports.

Conclude

Shelf-Life Determination

Regression-based shelf-life and retest-date estimation, producing the CTD 3.2.P.8 outputs needed for submission.

StabLIMS is part of the wider CORPEX LIMS family, so stability data connects to your QC laboratory, microbiology and QMS without re-keying. For Egyptian laboratories it ships Arabic-supported and EDA/EGAC-ready — see LIMS in Egypt.

ICH Q1A Stability Testing

ICH Q1A Stability Testing, Built In

Stability testing LIMS is only useful if it models the studies regulators expect. StabLIMS supports every ICH Q1A(R2) study type out of the box, and lets you configure storage conditions by climatic zone — important for Egypt and the wider MENA region's hotter zones (III/IVb).

Long-term (real-time) stability — 25°C/60% RH (or 30°C/65% RH), typically 12–36 months, to establish shelf life under recommended storage.
Accelerated stability — 40°C/75% RH for at least 6 months, to predict long-term behaviour and support provisional shelf life.
Intermediate & stress (forced degradation) — 30°C/65% RH and extreme conditions to identify degradation pathways and stability-indicating methods.

Each condition is tied to its chambers and pull schedule, so an excursion instantly flags every affected study. For a deeper walkthrough, read how stability LIMS software streamlines pharmaceutical stability testing.

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.

StabLIMS™ — Stability LIMS Software