GxP with Uncountable: A Validated Platform, Every Quarter
Regulated teams adopting an ELN/LIMS have traditionally faced a choice: validate the vendor's platform from scratch themselves, or take the vendor's word for it. Either way, every new release means re-proving compliance before it can go into production — a recurring cost that has nothing to do with the actual science.
Uncountable ships a complete vendor validation kit with every quarterly release (Feb, May, Aug, Nov): a Validation Master Plan, URS/FRS, FMEA risk assessment, a Requirements Traceability Matrix, pre-executed and signed OQ test evidence, 21 CFR Part 11 and EU Annex 11 actual results, and a Validation Release Certificate — independently audited each time. The platform underneath is a GAMP 5 Category 4 ELN/LIMS running in a single-tenant AWS environment, with ALCOA+ data integrity, full audit trails, bound e-signatures, and role-based access with SSO and MFA built in.
That kit feeds directly into your own IQ/PQ, so your team validates its configurations and custom integrations, not the platform — GAMP 5's shared-responsibility model, applied to every release.
Inherit the evidence, not the effort.
FAQs
It covers how Uncountable validates its ELN/LIMS platform for regulated customers: the GAMP 5 classification, the standards it aligns to, what's inside the vendor validation kit, the quarterly release cadence, and how validation responsibility is split between Uncountable and your team.
GAMP 5 is a risk-based framework for validating computerized systems in regulated industries. Uncountable is validated as a GAMP 5 Category 4 system — a configurable ELN/LIMS, validated out of the box by the vendor with clearly defined scope and exclusions — and aligns to 21 CFR Part 11 and EU GMP Annex 11, informed by ICH Q9 (R1) and the FDA's CSA draft guidance.
Every quarterly release ships with a Validation Master Plan, User & Functional Requirements (URS/FRS), an FMEA risk assessment with RPN scoring, a Requirements Traceability Matrix, pre-executed and signed OQ test evidence, 21 CFR Part 11 and EU Annex 11 actual results, and a Validation Release Certificate — reviewed by an independent GxP auditor.
Uncountable owns Installation & Operational Qualification (IQ/OQ), the quarterly kit, compliance documentation, and AWS infrastructure security. Your team reviews and leverages that kit to validate its own configurations and custom integrations (API, LIMS, ERP), run Performance Qualification/UAT, and handle final acceptance and release — so you're validating your setup, not the platform itself.
Four times a year — Feb 1, May 1, Aug 1, and Nov 1 — each following the same five steps: code freeze, OQ execution, risk review, kit release, and production deploy. Every release arrives with a refreshed validation kit and a GxP impact assessment, and single-tenant customers control their own release timing.
