A validated platform, every quarter.
Uncountable ships a complete vendor validation kit with every quarterly release, so regulated teams inherit the evidence, not the effort. A GAMP 5 Category 4 ELN/LIMS, aligned to 21 CFR Part 11 and EU GMP Annex 11.
Deployed by 175+ enterprise product development teams
Deployed by Enterprise R&D and Innovation Teams
Validation is a deliverable, not a project you inherit.
Many product development vendors hand you a platform and leave the qualification to you. Uncountable qualifies the platform itself and gives you the executed evidence, so your team's validation effort is scoped to your configurations and your integrations, not to proving the software works.
We execute
IQ and OQ
You execute
PQ and UAT
Every quarter
A refreshed kit
What auditors ask: inspection-ready by design
GxP capabilities, in one place
A configurable ELN/LIMS, validated out of the box by the vendor, with clear scope and documented exclusions.
21 CFR Part 11, Part 58 (GLP) and EU GMP Annex 11, with GAMP 5 (2nd ed.) and OECD GLP Advisory Document No. 17. Informed by ICH Q9 (R1) and the FDA Computer Software Assurance draft guidance.
Attributable, legible, contemporaneous, original, accurate; plus complete, consistent, enduring and available.
A dedicated environment per customer, with separate DEV, TEST and PROD and a choice of hosting region, so you control release timing.
February, May, August and November, each with an updated kit. On single-tenant deployments, you decide when to take it.
Walk-the-lab checklists, with findings tracked through to closure inside the same platform as the records.
The validation kit, shipped with every release
Our pre-executed OQ evidence feeds your IQ/PQ, so your team validates its own configurations rather than the platform.
Sharing responsibility, the GAMP 5 way
The vendor validation kit reduces your validation effort. It does not remove your accountability. Here is exactly where the line sits.
Uncountable
Your team
A stable, auditable baseline every quarter
The usual objection to cloud software in a regulated lab is that updates arrive on the vendor's schedule and break the validated state. Our release pipeline is built to answer that.
Two kinds of GxP, two kinds of buyer
GxP means "Good x Practice", a family of quality and regulatory standards across pharmaceutical, biotech, medical device, chemical and food industries. Uncountable is built for the two that govern laboratory and manufacturing quality data.
Good Laboratory Practice: non-clinical safety and environmental studies
Who regulates it
FDA (21 CFR Part 58) and EPA (FIFRA, TSCA) in the US. In the EU, national GLP monitoring authorities inspect and certify test facilities, with EMA, ECHA and EFSA as data users: all under the OECD Mutual Acceptance of Data framework.
Who works this way
Preclinical pharma and biotech, toxicology CROs, agrochemical and crop protection, specialty and industrial chemicals under REACH/TSCA, veterinary medicines, food and feed additives, and medical device biocompatibility testing.
Anchors we align to
21 CFR Part 5821 CFR Part 11 OECD GLP Principles OECD Advisory No. 17 GAMP 5 (2nd ed.)
Good Manufacturing Practice: production, testing and batch release
Who regulates it
FDA through CDER, CBER, CDRH and CVM in the US. In the EU, EMA coordinates while national competent authorities inspect, EDQM covers APIs and CEPs, and PIC/S harmonises inspection standards. The Qualified Person is a legally required role for batch certification.
Who works this way
Drug product and API manufacturing, biologics and ATMPs, CDMOs and CMOs, QC and contract testing labs, excipient and packaging suppliers, combination products, veterinary medicines, and medical devices under QMSR / ISO 13485, plus adjacent supplements, cosmetics and food.
Anchors we align to
21 CFR 210/21121 CFR Part 11 EudraLex Vol. 4 Annex 11 Annex 15ICH Q9 (R1)ICH Q10FDA CSAPIC/S PI 041
Downloads
The solution briefs your security, IT and quality reviewers will ask for: how the platform is secured, how it connects, and how it's validated.
.png)
Inherit the evidence, not the effort.
Book a walkthrough and we'll show you the validation kit for the current release, against your own workflows.
FAQs
Both. As a GAMP 5 Category 4 configurable product, Uncountable is qualified by us at the platform level; IQ and OQ executed and signed against each release, with the evidence shipped to you. Your configurations and integrations are Category 5 work and remain yours to validate, which is what PQ and UAT cover.
Updates land on a fixed quarterly cadence rather than continuously. Each release goes through code freeze, OQ execution, risk review and kit release before production deploy, and arrives with a GxP impact assessment so your quality unit can scope re-validation against documented change rather than re-testing everything. On single-tenant deployments you control when the release is applied.
Yes. Supplier qualification is a normal part of our sales process: we support vendor audits, quality agreements and documentation requests from your quality unit.
Uncountable runs single-tenant, so every customer gets a dedicated environment with separate DEV, TEST and PROD. Hosting region is chosen at deployment, including options for customers with data residency requirements.
The platform qualification and the kit are the same; what differs is the evidence your inspectors ask for. GLP facilities lean on study reconstruction, the Study Director and QA unit roles, archive and retention, and OECD Advisory Document No. 17 for computerised systems. GMP sites lean on batch release impact, supplier qualification and change control. We'll map the kit to whichever framework you're inspected against.
See the validated master plan for the current release.
