SHELF QMS is a unified quality management system purpose-built for accredited clinical and medical laboratories. It covers document control, staff training and competency management, non-conformance events and CAPA, proficiency testing, accreditation readiness, tasks, and forms — all in one integrated platform.

Which accreditation standards does SHELF support?

SHELF supports CAP, COLA, ISO 15189, CLIA, AABB, DNV GL, TJC, ISO 17025, CBAHI, CPSA, and NABL accreditation frameworks.

Is SHELF purpose-built for clinical laboratories or adapted from a generic QMS?

SHELF was designed from the ground up for accredited clinical and medical laboratories. It is not adapted from a manufacturing or generic enterprise QMS. Every module reflects actual laboratory workflows, inspection cycles, and accreditation requirements.

Does SHELF integrate document control with training and CAPA?

Yes. SHELF modules share a common data layer. A document approval can automatically trigger training assignments; an NCE can escalate to a CAPA; a CAPA action can reference affected SOPs. No manual handoff or integration configuration is required.

Can I see SHELF before requesting a demo?

Yes. An interactive demo environment is available at https://www.shelf-qms.ai/demo with no login or signup required. It runs with synthetic lab data so you can explore all modules in under 2 minutes.

SHELF

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Built for regulated laboratories

Quality management purpose-built for clinical laboratories.

Documents, training, NCE/CAPA, proficiency testing, and accreditation, all wired together the way your inspectors think. Not retrofitted from manufacturing.

Experience

Supports:CAPCOLACLIAISO 15189AABB

DASHBOARD

Metro Regional Lab

Open NCEs

Overdue CAPAs

Expiring Docs

Training Gaps

RECENT ACTIVITY

NCE-2024-022 opened2m ago

SOP-001 v3.1 approved1h ago

CAPA-2024-001 action closed3h ago

TR-004 completed · Kevin Nguyen5h ago

3 items require attention→

Built for labs accredited by

CAPCOLACLIAISO 15189AABBDNV GLTJC

The problem

Generic QMS wasn't built for laboratories.

Manufacturing QMS platforms force labs to adapt workflows designed for widgets, not specimens. SHELF was architected from the ground up for the 12 quality system essentials, CAP inspection logic, and the way accreditation surveyors actually think.

Lab-native workflows

Specimen custody, CLIA personnel requirements, PT peer group logic, and CAP checklist structure. Built in, not bolted on.

One audit trail

Every action is timestamped, signed, and searchable: document approvals, training completions, NCE acknowledgements, and CAPA closures.

Inspection-ready by design

SHELF surfaces the exact evidence package inspectors request, organized by checklist item, department, or time period.

Platform

Everything a clinical lab QMS needs.

Nine integrated modules. One platform. No spreadsheet workarounds.

DB

Dashboard

Unified QMS health: open NCEs, overdue CAPAs, expiring documents, and training gaps in one real-time view.

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DC

Document Control

Version-controlled SOPs, policies, and manuals with e-signature approval flows and automatic training linkage.

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TR

Training & Competency

Assign training plans linked to controlled documents. Track completion, competency scores, and expiration gaps.

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NCE

Non-Conformance Events

Capture, classify, and route quality events with severity triage, mandatory acknowledgement, and CAPA linkage.

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CA

CAPA

Root cause analysis, corrective and preventive action plans, effectiveness verification, and formal close-out.

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PT

Proficiency Testing

Schedule participation, record results against peer group ranges, and auto-trigger CAPAs on failures.

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AC

Accreditation

Map CAP, ISO 15189, COLA, and CLIA requirements to owners. Track readiness scores across accreditation cycles.

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TK

Tasks

Assign, track, and escalate quality tasks with due dates, priorities, and evidence-based closure requirements.

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FM

Forms & Quizzes

Configurable forms and knowledge assessments linked to training records, with submission audit trail.

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Built as a platform

Modules that talk to each other.

SHELF isn't a bundle of separate apps. Every module shares a common data layer. When an SOP is revised, training gaps surface automatically. When a PT survey fails, an NCE opens. When a CAPA closes, the linked accreditation checklist item updates.

See the integrations live

Document ControlTraining & CompetencySOPs auto-assign training

Training & CompetencyNCE / CAPATraining gaps trigger NCEs

Proficiency TestingNCE / CAPAPT failures auto-open NCEs

NCE / CAPADocument ControlCAPAs drive SOP revisions

CAPAAccreditationClosed CAPAs satisfy checklist items

Deployment model

One platform. Three deployment scales.

SHELF tiers differ by deployment scope — not features. Every tier ships with all nine modules, full accreditation support, and no feature gating.

Solo

One lab. One instance.

Full SHELF capability for a single lab, deployed on-premises or hosted. Ideal for independent or single-site clinical laboratories seeking a complete, accreditation-ready QMS.

All 9 modules included
On-premises or hosted deployment
Full accreditation support (CAP, ISO 15189, and more)
Standard implementation and onboarding

Nexus

Enterprise

Unlimited labs, one platform.

Multiple Nexus deployments under a single organization umbrella, with IQ/OQ/PQ validation, a dedicated customer success manager, REST API access, and co-development roadmap participation.

Unlimited sites and Nexus deployments
IQ / OQ / PQ validation package
REST API and integration framework access
Dedicated customer success manager

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Try it yourself

See every module in action.

Click through a fully interactive demo with realistic laboratory data. Dashboard, Document Control, Training, NCE/CAPA — all live, no login required.

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Ready to retire your QMS spreadsheets?

Talk to the SHELF team — we'll walk you through the platform and answer your questions.

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