Stability study software that schedules the pull-points and generates the report.
V5 designs the stability protocol (long-term, intermediate, accelerated), auto-schedules every pull-point across chambers, ties results to the specification limits, extrapolates shelf life per ICH Q1E, and generates the submission-ready stability report — no spreadsheet, no missed pulls.
What breaks without this.
Missed pull-points invalidate the study
Someone forgets the 6-month pull on chamber 3. That timepoint is gone. So is the shelf-life claim.
Trend analysis lives in Excel
Assay values are typed twice — once in the LIMS, once in the stability tracker — with no version control and no e-signature on the trend line.
Shelf-life extrapolation is a copy-paste job
The Q1E regression is done by hand on the day the report is due. Auditors ask to see the raw dataset. Nobody knows where it is.
Records-by-execution. Compliance, by design.
Protocol-driven pull-point scheduling
Long-term (25°C/60%RH), intermediate (30°C/65%RH), accelerated (40°C/75%RH), refrigerated, freezer — every timepoint calendared with role-based alerts and escalation on overdue.
Direct LIMS link — no re-keying
Assay, impurities, dissolution, water content flow from the LIMS into the stability record; specification limits enforced automatically.
ICH Q1E regression built in
Linear, log, reciprocal regression with confidence intervals, retest date and shelf-life recommendation — with the underlying dataset preserved for the reviewer.
OOS on stability triggers investigation with hold
A failing timepoint opens an OOS investigation, holds the batch in commerce, and flags every batch on the same specification.
Submission-ready report
ICH-format stability summary, tabulated data, regression plots, chamber qualification appendix, exported as PDF/A.
What to look for when you're buying.
Stability studies fail on scheduling, chamber excursions, and pull integrity. Criteria below matter more than the pretty charts.
Pull schedule enforcement
What it tests: Are pull points scheduled with pre-notification and missed-pull records?
Why it matters: Missed pulls invalidate points.
V5: Schedule per protocol with pre-notification; missed pull is a first-class record.
Chamber excursion linkage
What it tests: Do excursions link to the samples in the chamber?
Why it matters: Excursion impact analysis is required.
V5: Chamber telemetry linked; affected samples surfaced.
Trend against ICH Q1E
What it tests: Are trends analysed per ICH Q1E for shelf-life determination?
Why it matters: Otherwise shelf-life is a guess.
V5: Q1E-aware regression per attribute.
Bracketing / matrixing
What it tests: Are Q1D bracketing and matrixing designs supported?
Why it matters: Reduces sample count with defensible design.
V5: Q1D designs native.
OOS at stability
What it tests: Do OOS at stability route to full OOS workflow?
Why it matters: Stability OOS is a common finding.
V5: Stability OOS uses the same OOS lifecycle.
Spreadsheet vs legacy QMS vs V5.
Stability tooling.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| Pull schedule | Manual calendar | Reminder | Enforced with missed-record |
| Chamber excursion linkage | Manual | Optional | Live |
| Q1E trending | Excel | Add-on | Native |
| Q1D designs | Manual | Rare | Native |
The clauses, verbatim — and how V5 answers each.
ICH Q1 series expectations.
Stability testing of new drug substances and products...
V5: Native protocol modelling with intervals and conditions.
Evaluation for stability data...
V5: Regression, ANCOVA and shelf-life estimation native.
Bracketing and matrixing designs...
V5: Both designs supported with rationale capture.
There shall be a written testing program designed to assess the stability characteristics...
V5: Written program is the executed protocol in V5.
Step by step on the floor.
Stability in V5.
- 1Design
Protocol under change control
Attributes, intervals, conditions, design captured.
- 2Enroll
Batches enrolled
Chamber assignments and sample counts derived.
- 3Pull
Scheduled pulls executed
Pre-notification, execution capture, missed-pull record if applicable.
- 4Test
Results captured
LIMS interface or in-system capture.
- 5Trend
Q1E analysis
Live regression; shelf-life estimates updated.
- 6Report
Regulatory-ready output
Signed report per protocol.
The math, with the assumptions visible.
Stability ROI is labour and defensibility.
Missed pull rate
Enforced schedule.
Report assembly time
Live regression, structured protocol.
Excursion impact response
Live chamber-to-sample link.
Programs typically recover the module cost within the first annual report cycle.
What changed on the floor.
Setting
A pharma running 40 concurrent stability studies.
Before
Missed pulls occurred quietly; excursion investigations took days.
After
Missed pulls surfaced as records; excursion investigations under an hour; last annual reports assembled in 2 days each.
Proof points
- Pull-points calendared and escalated — no missed timepoints
- LIMS values flow direct — no double-entry, no transcription error
- ICH Q1E extrapolation with the raw regression dataset preserved
- Chamber qualification (IQ/OQ + mapping) linked to every study
Built to satisfy
- ICH Q1A(R2) (stability testing of new drug substances and products)
- ICH Q1E (evaluation of stability data)
- 21 CFR 211.166 (stability testing)
- EU GMP Annex 19 (reference and retention samples)
- WHO TRS 1010 Annex 10 (stability of pharmaceutical products)
Related on V5
Frequently asked questions
Does V5 handle chamber mapping and qualification?+
Yes — chamber IQ/OQ, temperature/humidity mapping profiles, and continuous monitoring alarms are linked to every study; excursions auto-flag the affected timepoints.
Can V5 support bracketing and matrixing designs?+
Yes, per ICH Q1D. The protocol builder captures the reduced design, the statistical justification, and the residual coverage — audit-defensible.
What about bulk / API stability?+
Same engine. Bulk API, drug substance, drug product, finished dose, and repackaged/relabelled product all run as protocol variants.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.