Solutions
/
Analytical QC
/
Stability Studies

Stability study LIMS from protocol to shelf life

ICH stability programs with protocol design, chamber management, pull scheduling, results aggregation, and Q1E regression, in one system.

THE PROBLEM

Where legacy LIMS break down

A stability program is a calendar that runs for years. Every batch on study has a condition matrix, a timepoint schedule, and a set of tests at each pull, and the lab has to hit every pull on the exact right day. Most labs manage that in a spreadsheet that one person understands.

Results scatter across the tests that generate them. Assay from chromatography, dissolution from dissolution system, micro from the micro lab. And someone must assemble the timepoint by hand to the trend.

Labbit builds the protocol as a controlled entity, generates pull worklists from the schedule, routes pulled samples into the right test workflows, aggregates results per timepoint automatically, and runs ICH Q1E regression with out-of-trend flagging. The shelf-life projection updates as data lands.

‍

PRE-CONFIGURED WORKFLOWS

Workflows out of the box

Built visually in BPMN, adapted to your lab, and changed without a vendor release.

Stability Protocol Design & Enrollment; Chamber Management & Monitoring; Pull Scheduling & Sample Accountability; Stability Testing & Results Aggregation; Shelf-Life Trending & Regression; Photostability (ICH Q1B); In-Use & Excursion Stability; Stability Commitment Reporting
Targeted Amplicon Sequencing

Instruments and platforms

Instruments and platforms

Binder KBF; ESPEC; Caron; Kaye ValProbe RT; Atlas Suntest CPS+; Q-SUN photostability chambers
This is some text inside of a div block.

FAQ

Frequently Asked Questions

Does Labbit generate stability pull schedules?

+
-

Yes. Pull worklists are generated from the protocol timepoint schedule, with chain of custody from chamber to bench.

Can Labbit trend results and project shelf life?

+
-

Yes. ICH Q1E regression runs per batch and pooled, with out-of-trend flagging and expiry projection that updates as timepoints complete.

Is chamber monitoring integrated?

+
-

Yes. Chamber inventory, qualification status, and continuous temperature and humidity monitoring with excursion-to-impact assessment.

Does Labbit support photostability and in-use studies?

+
-

Yes. ICH Q1B photostability with dose tracking and short-term in-use and excursion studies are pre-configured.

+
-

SEE IT ON YOUR ASSAYS

See your workflow running in Labbit

Bring an assay your team runs today. We’ll show you how it’s configured, executed, and reviewed.