Stability study management software for ICH stability programs
QLogix Stability Study Management runs a pharmaceutical stability program in one system, on the same audited records as the LIMS and the QMS. Protocols are built on the approved LIMS specification, with ICH Q1A(R2) storage conditions, time points, pull windows and the tests at each time point. Studies compute the pull schedule from each batch's T0 and print a barcode for every pull; scanning the label at the qualified chamber records the pull and registers the LIMS sample with the time point's tests in one step. Reminder and escalation emails go out before each window opens and when a pull is missed. The shelf life is estimated under ICH Q1E by the system in seconds (regression, poolability at the 0.25 level, the 95% confidence bound, the extrapolation limit), with out-of-trend detection and significant change, instead of manual calculation, Excel or JMP. QA approves the protocol and the study report with electronic signatures.
What the module does
- Stability protocols on the approved LIMS specification: its tests become the protocol's attributes with their limits, each trended in the direction it moves (or both), with a linear or log (first-order) model, and assays flagged for the 5% significant change.
- ICH Q1A(R2) and Q1B conditions as presets (25 °C/60% RH, 30 °C/65% RH, 30 °C/75% RH, intermediate, accelerated 40 °C/75% RH, refrigerated, frozen, photostability) or your own, each with time points, pull windows, units and a test matrix by time point.
- An AI review of the protocol against ICH Q1A(R2), Q1B, Q1E and Q5C and the climatic zones of the markets, before QA approves it; a change is a new protocol version, and running studies keep the version they started on.
- Batches placed in qualified chambers: each chamber is a CMMS asset, and placement is refused while its temperature or humidity calibration is overdue, an out-of-tolerance result is undecided or the asset is out of service.
- Time-point scheduling: the pull schedule is computed from each batch's T0, by calendar month, with each pull's window, units and tests, and a Code 128 barcode on every pull label.
- Barcode sample tracking: a scan at the chamber finds the pull across every study, checks its window and the chamber's state at that moment, records the time and units, and registers and receives the LIMS sample with only the tests scheduled at that time point; a pull outside its window needs the reason.
- Sample pull reports: every scheduled pull across studies, missed, due now or in the next days, printed by day with the chamber, location and barcode.
- Email notifications with escalation: the pull team and the study manager are reminded ahead of each window, when it opens and on its last day; a missed pull is escalated to the stability manager and QA, and raises a critical alert.
- Results read back from the LIMS by condition, attribute, batch and time point, with out-of-specification results and results still in review marked; only QA-approved results enter the statistics.
- ICH Q1E statistics computed by the system: regression per batch, poolability by analysis of covariance at 0.25 (slopes, then intercepts), the 95% confidence bound for the mean, the shelf life where it crosses the limit and the supported shelf life within the extrapolation limit, with a regression chart for each attribute.
- Out-of-trend detection by regression control chart (the prediction interval of each batch's earlier results) and significant change at accelerated and intermediate conditions, each out-of-trend result dispositioned with an investigation or a reason.
- The study report: an AI-drafted narrative that quotes the system's numbers, the shelf life and storage statement stated by the study manager, and QA approval with an electronic signature; a locked PDF with the results, the evaluation and the charts.
Why one system for stability data
Stability programs often live across a spreadsheet of pull dates, the LIMS, a statistics package and a report in a word processor. Every handoff is a transcription and a chance to miss a pull, copy a result wrong or run a regression in unvalidated software. Here the schedule, the samples, the results, the statistics and the report are the same records: a pull cannot be missed without an alert and an escalation, a result is never retyped, and the shelf-life calculation is the system's, checked against statsmodels and SciPy to 1e-6, with its inputs fingerprinted in the signed evaluation.
How it fits the platform
Pulls are LIMS samples: they are tested, judged against the specification and approved in the LIMS like any sample, results can be posted from the electronic lab notebook, and an out-of-specification result is investigated there. Chambers are CMMS assets with their calibration records, so a chamber out of calibration blocks placement and is flagged at the pull. An out-of-trend result opens an investigation pre-filled from the study, and a change control (a new supplier, a site transfer, a process change) can link to the commitment study it needs. Q Intelligence lists studies with missed pulls, open out-of-trend results or a shelf life at risk.
Where people decide
The system schedules, judges and calculates; people decide. QA approves each protocol before batches are placed on it, the analyst records each pull, a pull outside its window or from a chamber that is not fit needs a reason, each out-of-trend result needs a disposition, and QA approves the shelf life and storage statement in the study report with an electronic signature.
Questions about Stability Study Management
What is stability study management software?
Stability study management software plans and runs pharmaceutical stability programs: the protocol, the storage conditions and time points, the pull schedule, the samples and results, the shelf-life statistics and the report. In QLogix it is built on the LIMS, so every pull is a LIMS sample tested against the approved specification, and the ICH Q1E statistics are computed from the approved results.
How is the shelf life calculated?
Under ICH Q1E: each trended attribute is regressed on time per batch, poolability is tested by analysis of covariance at the 0.25 level (slopes, then intercepts), and the shelf life is where the 95% confidence bound for the mean crosses the acceptance limit, the shortest over the batches. The supported shelf life is held to the extrapolation Q1E allows: twice the long-term period covered, at most 12 months beyond it.
Do we still need Excel or JMP for stability statistics?
No. The regression, the poolability tests, the confidence bounds and the shelf life are computed by the system in seconds from the approved LIMS results, and the engine is checked against statsmodels and SciPy on known datasets. The stored evaluation records the engine version and a fingerprint of the values it read, so the signed number can be traced to its data.
How are missed pulls avoided?
The schedule is computed from each batch's T0, the pull team and study manager are emailed before each window opens, when it opens and on its last day, and a pull missed is escalated to the stability manager and QA and raises a critical alert. The pull report lists every pull due across studies with its chamber and barcode.
How does barcode sample tracking work?
Each pull has a Code 128 barcode with the study, batch, condition and month. Scanning it at the chamber finds the pull across studies, checks the window and the chamber's calibration and maintenance state, and records the pull with the LIMS sample registered and received in one step.
How are out-of-trend results detected?
A result outside the prediction interval of the line through the same batch's earlier results at that condition is out of trend (the regression control chart method). Each one is recorded for a disposition: an investigation opened from it, or the reason it is not out of trend.
How is it licensed?
Per user per month, on its own or with the LIMS and other modules, ordered by purchase order from the client portal. There is no card payment or self-serve plan.
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