The digital backbone of regulated manufacturing.
T2 Software helps Life Sciences manufacturers digitize operations — from batch record to release — with NEO, an enterprise platform built for GxP environments.
Complete digital transformation. Not just software.
We design, implement, validate and operate the systems that run regulated production — so quality, engineering and operations work from a single digital thread.
One platform, from shop floor to release.
NEO connects execution, quality and equipment in a single system of record for manufacturing.
We deliver projects, not licenses.
Every deployment includes the engineering, validation and infrastructure needed to run in production — end to end.
- 01ImplementationFrom process mapping to deployment, led by engineers who know GxP manufacturing.
- 02ValidationCSV documentation and execution aligned with GAMP 5.
- 03TrainingOperators, reviewers and administrators ready from day one.
- 04Go LiveCutover to production with our engineers beside your team at every step.
- 05HypercareIntensive post-go-live support until the operation runs stable on its own.
Latest insights

Annex 22 is still a draft. Here's what you can already do with AI in GMP
The draft EU GMP Annex 22 (public consultation July–October 2025) does not ban AI on the shop floor. It separates where a model may decide from where it may only assist. Here is what you can put in place now, without rework when the final text lands.

ICH Q12: CMC lifecycle with a change map
Every plant knows the situation: a small process improvement—a slightly narrower range, an alternate site, an analytical adjustment—and the regulatory schedule starts setting the pace of operations. Variation, regulatory submission, review queue, and validation that seems to reopen more than necessary. Some of that burden is real and necessary. Some of it comes from not…

ICH Q8/Q11 → floor: design space in EBR/MES
Design space and control strategy only hold on the floor if EBR/MES enforces what development registered — the registered range is not a shift suggestion.
Let’s digitize your operation.
Talk to our engineers about your digital manufacturing roadmap — from a single line to a global rollout.
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