GxP with Uncountable: a validated platform, every quarter
A quarterly software release should not force regulated teams to repeat platform validation from scratch. It should provide the evidence needed to validate what changed and focus internal effort on the configurations that are specific to the organization.
Traditional validation approaches can make upgrades slow and costly. Teams must interpret release changes, collect supplier documentation, map requirements, execute testing, and maintain an inspection-ready evidence trail, often with incomplete materials or unclear division of responsibility.
For GxP compliance, Uncountable ships a complete GAMP 5 validation kit with every quarterly release, including a validation master plan, failure-mode and effects analysis, requirements traceability matrix, and signed operational-qualification evidence. This allows regulated teams to validate their own configurations while using supplier documentation for the platform release.
This solution brief is for pharmaceutical and other regulated R&D, quality, and IT teams that need a repeatable approach to validated platform releases.
Inside this solution brief:
- What a quarterly GAMP 5 validation kit includes
- How supplier evidence supports release-validation activities
- The role of a VMP, FMEA, and RTM in validation documentation
- How signed OQ evidence supports controlled testing
- Why teams should validate their configuration alongside the platform evidence
Keep your validated environment current without treating every release as a new validation project. For more depth, read the white paper Document control and the limits of modern quality management systems.
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scope and exclusions) and aligns to 21 CFR Part 11 and EU GMP Annex 11, informed by ICH Q9 (R1) and the FDA's CSA draft guidance.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.
