Stability LIMS Software — the CORPEX LIMS Stability Module
Run ICH Q1A stability studies end to end — protocols, automatic pull scheduling, chambers, stability testing and ICH Q1E shelf-life evaluation. Available on its own or as part of the CORPEX LIMS platform.
Watch: stability studies in CORPEX LIMS
ICH Q1A(R2) pull points, chamber excursions that flag every exposed study, and ICH Q1E shelf-life evaluation.
Stability Laboratory Information Solution
The Stability module of CORPEX LIMS models stability protocols with their storage conditions (25°C/60% RH long-term, 30°C/65% RH intermediate, 40°C/75% RH accelerated) and pull points at 0, 3, 6, 9, 12, 18, 24 and 36 months. Climatic zones are configurable, and the module advises which conditions a zone calls for.
Pulls are scheduled automatically from the protocol and shown on a stability calendar. The module is available on its own or as part of the CORPEX LIMS platform.
Shelf Life You Can Defend
Every batch of a product is evaluated together, as ICH Q1E asks: batch poolability, regression with a 95% confidence bound, the shelf life the data actually supports, and an out-of-trend register. When the data does not support the claimed shelf life, the screen says so before an inspector does.
It serves stability teams in quality control and in R&D. Results are entered in electronic worksheets, reviewed with electronic signatures and recorded in a tamper-evident audit trail, so the whole study is tracked without printing anything.
Complete Stability Study Management, in One System
The Stability module 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.
Stability Protocol Creation
Define studies, conditions, time points, tests and specifications from reusable protocol templates aligned to ICH Q1A, approved with an electronic signature.
Sample Pull Scheduling
Pulls are scheduled automatically from the protocol and shown on a stability calendar, so every time point is visible ahead of time.
Chambers & Excursions
Chambers are linked to the studies inside them. A recorded excursion flags every study exposed, study by study, with chain of custody for stability containers.
Test Execution & Data Capture
Electronic worksheets capture stability-indicating results directly, with a full ALCOA+ audit trail.
Trend Analysis & Reporting
Trending across time points and batches, with an out-of-trend register and a printable evaluation report.
Shelf-Life Determination
Regression with a 95% confidence bound and ICH Q1E batch poolability show the shelf life your data supports.
The Stability module is available on its own or as part of the CORPEX LIMS platform, so stability data can share samples, results, Certificates of Analysis and OOS investigations with your QC laboratory and microbiology without re-keying. For Egyptian laboratories it ships Arabic-supported and EDA/EGAC-ready — see LIMS in Egypt.
ICH Q1A Stability Testing, Built In
Stability testing LIMS is only useful if it models the studies regulators expect. The Stability module supports the ICH Q1A(R2) study types out of the box, and climatic zones are configurable — 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 stability — 30°C/65% RH, used when accelerated data shows a significant change.
Each condition is tied to its chambers and pull schedule, so a recorded excursion flags every study exposed. For a deeper walkthrough, read how stability LIMS software streamlines pharmaceutical stability testing.
Stability Module — Frequently Asked Questions
What is the CORPEX LIMS Stability module?
The Stability module of CORPEX LIMS runs pharmaceutical stability programmes: protocols with storage conditions and pull points, automatic pull scheduling, chambers linked to studies, stability results with e-signatures and a tamper-evident audit trail, and ICH Q1E shelf-life evaluation. It is available on its own or as part of the CORPEX LIMS platform.
Which ICH conditions does the Stability module track?
Protocols carry ICH Q1A(R2) storage conditions: long-term 25°C/60% RH, intermediate 30°C/65% RH and accelerated 40°C/75% RH, with pull points at 0, 3, 6, 9, 12, 18, 24 and 36 months. Climatic zones are configurable, which matters for Egypt and the MENA region's hotter zones.
How does the Stability module handle chamber excursions?
Chambers are linked to the studies stored in them. When a chamber excursion is recorded, every study exposed to it is flagged, study by study, so QA can assess the impact.
Does it support 21 CFR Part 11 and EDA requirements?
Yes. Protocol approval, result review and release decisions carry electronic signatures (name, time and meaning), and every change is written to a hash-chained, tamper-evident audit trail, supporting FDA 21 CFR Part 11 and Egyptian Drug Authority and EGAC ISO/IEC 17025 expectations.
Is the Stability module suitable for Egyptian pharmaceutical labs?
Yes. CORPEX implements it on site across Egypt, with Arabic and English support and pricing in Egyptian pounds. See our LIMS for Egyptian laboratories page for how it fits local EDA and EGAC requirements.
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Contact us today to learn how the CORPEX LIMS Stability module can streamline your operations.
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