LIMS

Uncountable's Quality Control LIMS is an AI-powered laboratory information management system designed for enterprise R&D and manufacturing teams in regulated industries. It connects test results directly to formulations, raw material lots, and production history, eliminating the disconnected spreadsheets, siloed systems, and institutional knowledge gaps that slow down root cause analysis and leave teams scrambling during audits.

Built for both single-site labs and multi-plant global operations, Uncountable's QC LIMS replaces fragmented quality workflows with a unified platform that links QC data to product, process, and lifecycle information — enabling faster decisions, consistent execution across sites, and continuous audit readiness.

Centralized Quality Data and Documentation

• Manage quality events, control plans, test results, deviations, and approvals in a single platform serving both R&D and manufacturing teams.
• Retrieve past results, reports, and approvals quickly using advanced filtering and structured, searchable records with full traceability.
• Connect test results directly to specific formulations, batches, or production runs for context-rich, actionable insights.
• Combine data visualizations with AI tooling to accelerate root cause analysis and resolve out-of-spec incidents and deviations faster.

Workflow Automation and Reduced Manual Effort

• Workflow Automation — Configure end-to-end workflows for test reviews, CAPA, and non-conformance management to standardize execution and reduce cycle times.
• Task and Notification Management — Automatically assign tasks and send alerts to keep work moving, prevent bottlenecks, and eliminate missed handoffs.
• Reduced Administrative Overhead — Replace spreadsheets and manual tracking with fully digital execution to save time and improve traceability across the quality lifecycle.

Complete Traceability and Audit Readiness

• Built-In Audit Trails — Automatically log every change, action, and decision across the QC LIMS to maintain a complete, tamper-evident record.
• Version Control Across Records — Track iterations of methods, tests, and reports with full visibility into historical changes.
• Compliance-Ready Documentation — Generate exportable reports to meet ISO, GxP, FDA 21 CFR Part 11, and other industry-specific regulatory requirements.
• Cross-Site Alignment — Harmonize quality practices across multiple labs or manufacturing plants to maintain consistent standards globally.

Integration with R&D and Production Systems

• Built-in QMS and PLM — Link quality events directly to formulations, samples, and experiments, and trace non-conformities through a full CAPA process without leaving the platform.
• Instrument and ERP Integration — Automatically pull in instrument results and sync with operational systems, including all leading ERPs. Over 400 instrument types are supported.
• Unified Data Backbone — Reduce data duplication and ensure consistency across platforms, teams, and sites by consolidating LIMS, ELN, and QMS capabilities in one system.

Structured Implementation and Phased Rollout

• Phase 1 – Discovery and Scoping: Uncountable maps current QC workflows, instruments, data sources, and compliance requirements to identify what migrates, what changes, and what stays.
• Phase 2 – Configuration and Data Migration: The LIMS environment is configured with test methods, spec limits, approval workflows, instrument connections, and role-based access. Structured historical data is migrated and validated with side-by-side comparison reports.
• Phase 3 – User Acceptance Testing: Structured UAT scenarios based on real workflows confirm configurations, calculations, permissions, and integrations before validation. Issues are logged, prioritized, and resolved prior to go-live.
• Phase 4 – Parallel Run and Validation: The new system runs alongside existing processes while the validation team confirms data integrity, audit trails, and regulatory compliance before cutover.
• Phase 5 – Go-Live and Hypercare: Full cutover with dedicated embedded support during the first weeks of live operation to resolve issues in real time.
• Phase 6 – Optimization and Scale: After stabilization, the system is extended to additional sites, refined workflows, custom reports, and additional instrument connections.

Ongoing Support After Go-Live

• A dedicated Account Manager familiar with your specific workflows and team.
• Quarterly business reviews to identify optimization opportunities and track ROI.
• Priority support with SLAs tailored to manufacturing environments.
• Continuous platform updates with guided rollouts and no surprise breaking changes.

Uncountable's QC LIMS is designed to support transitions in regulated environments, including ISO 9001, GxP, and FDA 21 CFR Part 11 contexts. Role-based training, parallel run phases, and a change management approach built for manufacturing realities ensure that operators, QC leads, and validation teams can adopt the system confidently without production downtime or compliance risk.