Follow the protocol.See the pull dates.Keep study history.
Put each study lot on an approved protocol, see every timepoint coming due, and send pulls to the sampler with the right tests attached.
Time points stay connected to the study.
Follow one pull
A study on an approved protocol
Each study links a lot and item to a protocol.
How stability studies work: protocol, schedule, pull and test
1. A study on an approved protocol
Each study links a lot and item to a protocol.
The protocol sets the storage condition and required tests.
Protocols are approved and versioned before use.
- Versions
- Protocols are cloned to revise, with version history and a change log.
Your protocol and timepoints follow your own stability programme.
STB-0007
Stability study
- Item
- FG-118 Tablets 10 mg
- Lot
- L-26-0712
- Protocol
- Long-term · approved
- Storage condition
- As set in protocol
- Tests
- Assay · dissolution · water
The protocol carries the test panel.
2. Timepoints coming due, at a glance
Scheduled and overdue timepoints in one list.
Filter by the next 7, 30 or 90 days.
See pulls already requested and awaiting draw.
- Sensors
- Chamber temperature can come from connected sensors where set up.
Chamber monitoring itself needs connected sensors or your own records.
Stability Pulls
Lab
- Overdue
- 0
- In window
- 2
- Next 7 days
- 3
- Next 30 days
- 9
- Awaiting draw
- 1
Nothing slips past its window.
3. One click sends the pull to the sampler
Raise a sampling request from the due timepoint.
The protocol's tests are attached automatically.
The sampler terminal fulfils it and the pull advances.
- Kiosk
- Samplers see stability draws on their lab kiosk.
Who can raise and draw pulls is set by your administrators.
STB-0007 · 6-month pull
Request sample
- Trigger
- Stability due
- Panel
- From protocol
- Sent to
- Sampler terminal
- Status
- Requested
- Pull
- Advances when drawn
The supervisor requests; the sampler draws.
4. Results into the Lab Queue
Samples join the normal lab queue.
Results plot on each method's SPC chart.
A failing result follows the OOS workflow.
- Reports
- Results are available to lab reports and the annual product review.
Shelf-life conclusions are made by your quality team, not by V5.
Lab Queue
STB-0007 · 6 months
- Assay
- 99.4%
- Dissolution
- Pending
- Water
- 2.1%
- SPC
- Plotted by method
- Out of spec?
- OOS workflow
Tested like any other sample.
Where stability fits
Stability uses the same lab methods, SPC charts and OOS workflow as release testing.
- Lab & QCSample plans, results against limits and out-of-spec review.See Lab & QC
- This pageStability studiesPull schedules on approved protocols, sent to the sampler.
- SPC & TrendingLevey-Jennings charts and Westgard rules on every result.See SPC & Trending
- OOS InvestigationsPhase IA, IB and II checklists with signed advancement and closure.See OOS Investigations
AI and Stability studies
The time-point evidence stays authoritative
The time-point evidence stays authoritative
Use AI help to explore study schedules, sample identity and result review. Shelf-life conclusions require suitable study evidence, not a prediction from an assistant.
Everything in this feature
What stability studies use, and which plan each item needs. Compare plans
Studies on approved protocols
EnterpriseLot, item, storage condition, tests.
Pull schedule
EnterpriseOverdue, in window, next 7/30/90 days.
Sampling requests
EnterpriseSent to the sampler terminal.
Results in the lab queue
EnterpriseWith SPC and OOS.
V5 keeps the schedule. People draw, test and decide shelf life.
Explore the sample records.
Open a sample report to review its contents, supporting references and how the record is built.
UltimateSample register
Stability pull schedule (CSV)
Test & release
Quality Evidence & Management Review Buyer Guide
A 19-page guide to quality decisions you can show evidence for: management review, lab results, approved suppliers and customer document sharing.
- Management review: inputs to owned decisions, with a worked quarterly review
- Lab results: specifications, out-of-specification investigation and release boundaries
- Approved suppliers: scope, evidence, expiry and a lapsing certificate
- Customer document sharing: approval, revision, withdrawal and portal evaluation
Plus Connected evidence map, RACI, implementation plan, RFP and scored checklist.
Get the quality evidence guideWe ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy.
UltimateFree buyer guide
Quality Evidence & Management Review Buyer Guide
Straight answers.
What buyers ask us first about Quality & Laboratory.
Does V5 release product automatically?
No. V5 gathers results and records for review, but a person in quality decides and signs the release.
What does the lab side cover?
Lab and QC covers sampling, instruments, methods, results and out-of-spec handling, with LIMS, lab notebook, stability and SPC on top. These are Enterprise features; see Compare details on the pricing page.
Can we use V5 in a validated environment?
For validation-controlled operations, V5's route is Enterprise private cloud with controlled upgrades and IQ/OQ support. Your team still validates V5 for its intended use.
More of the product
Start with one area. Add the rest when you are ready.
Warehouse & TraceabilityExplore 
Production & PlanningExplore 
This feature's areaQuality & LaboratoryExplore 
Documents & TrainingExplore 
Equipment & PerformanceExplore 
Orders & IntegrationsExplore
Try it with one study you run now.
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