Change Control & Validation
Every configuration change ships as a versioned changeset with a reviewable diff and a
deployment record, so you know exactly what changed, who deployed it, and what needs requalification.
Every configuration change ships as a versioned changeset with a reviewable diff and a
deployment record, so you know exactly what changed, who deployed it, and what needs requalification.
THE PROBLEM
In many lab systems, a workflow change means custom scripts or vendor services. Without native versioning, it's hard to test a change safely, roll it back, or keep development and production environments in sync, so upgrades turn slow, disruptive, and developer-dependent.
Validation compounds the cost. CSA asks labs to focus testing where risk actually lives, but that only works when you can see exactly what a change touched. When nobody can say, the safe answer is to revalidate broadly, and the efficiency CSA promises never arrives. Labs start deferring changes they need, and the SOP and the system drift apart.
CAPABILITIES
Workflow and workbook changes are packaged into a versioned changeset. Each deployment is recorded in the environment's history with the changeset ID, who deployed it, when, and a categorized summary of what was added, modified, or removed.
Every change is categorized by component and type of modification, so QA can see exactly what a deployment touched. That's the visibility risk-based CSA depends on: scope testing to what changed instead of retesting the whole configuration.
Build and test in development and validation environments, then promote the same changeset to production after reviewing its diff. A previously deployed changeset can be restored through the same review.
Labbit provides IQ and OQ documentation, release notes, and traceability matrices that your team can use under a risk-based CSA approach. Labbit maintains the validated state of the core platform; your team qualifies its configuration for your intended use.
HOW IT WORKS
01
A change is built in Designer or in configuration files and captured as a draft changeset.
02
The draft is compared visually with the version it started from, then deployed to a development or validation environment for testing.
03
The approved changeset is promoted to production. The deployment history records what changed, who deployed it, and when, and any earlier changeset can be restored.
IN PRACTICE
GMP BIOMANUFACTURING
Review by exception, not by binder
ANALYTICAL QC
HPLC and GC testing against spec
ANALYTICAL QC
Protocol through pull point to trend
DIAGNOSTIC TESTING
PCR and molecular assays, validated flows
How does Labbit reduce revalidation effort?
By showing exactly what each change touched. Every deployment carries a categorized summary of what was added, modified, or removed, with visual side-by-side comparisons. QA can scope testing to that record under a risk-based CSA approach, supported by Labbit's IQ and OQ documentation for the core platform.
Does Labbit support a Computer Software Assurance (CSA) approach?
Yes. Labbit is developed and released under a quality management system aligned with GAMP 5 and CSA principles. For your own assurance activities, every deployment shows exactly what changed, so you can scale testing to the risk of each change and use Labbit's IQ and OQ documentation for the core platform rather than retesting it.
Do Labbit software upgrades affect our validated configuration?
Upgrades are designed not to change your configuration. Labbit maintains the validated state of the core platform under formal change control, with impact assessment, testing, and approval before each release. Every version ships with release notes that flag anything relevant to configured workflows, so your team can scope any testing to what actually changed.
Does Labbit help with IQ, OQ, and PQ?
Yes. Labbit provides Installation and Operational Qualification documentation, release notes, and traceability matrices. Your team performs Performance Qualification for its intended use, with support from Labbit's implementation services if needed.
Does Labbit replace our QMS change control?
No. Labbit's change control governs changes to your Labbit configuration and workflows. It works alongside your quality management system's change control process rather than replacing it.
CHANGE WITHOUT THE RISK
We'll walk a real workflow change through Labbit, from draft to promoted changeset,
and show exactly what the record looks like for QA.