Laboratory compliance documentation and regulatory management

Regulatory Compliance

ComplianceCall

Comprehensive CLIA governance for every tier of laboratory operations — from single-site clinical labs to multi-facility consulting practices. Know before your inspector does.

Platform Overview

The only CLIA platform that tells you before your inspector does.

The platform maintains live connections to the CLIA Federal Register and the FDA CLIA test database. When a new QC requirement is promulgated, ComplianceCall tells you before your next survey does. Your compliance dashboard updates automatically — not at your next review cycle.

Technical Consultants overseeing multiple facilities manage all client laboratories from a single organisational account, with configurable access controls, consolidated compliance analytics, and cross-laboratory benchmarking that siloed per-laboratory tools cannot provide.

Compliance Module Coverage 21 modules
  • Personnel Management & Credentialing
  • Quality Control Management
  • Document Control & E-Signatures
  • CLIA Survey & DTag Management
  • Precision, Accuracy & Linearity Studies
  • Laboratory Licensing & CMS-116
  • FDA Database & Federal Register Integration
  • Mini-LIS: Requisitions & Result Management
  • Inventory Management & Reorder Automation
  • Instrument Lifecycle & Calibration Records
+ 11 additional modules — see full documentation
Laboratory compliance team reviewing documentation

“Our last survey was the first in six years where no documentation deficiencies were cited. The DTag prevention module flagged three issues before the inspector arrived.”

R. Patel, MT(ASCP) — Technical Consultant, Independent Laboratory Consulting

Key Capabilities

Designed for every role in the laboratory compliance hierarchy.

DTag prevention engine

Proactive identification of documentation gaps and process deviations that generate Deficiency Tags before they are cited in a CLIA survey.

Live Federal Register sync

Automatic ingestion of CLIA regulatory updates. New requirements appear in your compliance dashboard within 24 hours of Federal Register publication.

Multi-laboratory management

Technical Consultants managing multiple facilities see consolidated compliance status, cross-laboratory analytics, and configurable access tiers in a single account.

E-signature document control

Full document lifecycle management with legally binding e-signatures, complete version history, access logs, and automated retention scheduling.

QC schedule automation

Automated QC scheduling based on your test menu, with alerting for missed events and direct integration into the instrument calibration record.

Survey-ready reporting

One-click export of all documentation packages required for CLIA survey preparation, organised by standard and condition of participation.

Who Uses ComplianceCall

Built for every laboratory compliance role.

Clinical Laboratory Directors

Maintain a continuously auditable compliance record across all 21 CLIA domains. Eliminate the scramble before surveys.

Technical Consultants

Manage all client laboratories from a single account. Cross-laboratory benchmarking and consolidated analytics no siloed tool can provide.

Quality Managers

Automate QC scheduling, track personnel competency deadlines, and manage document revisions with legally binding e-signatures.

Laboratory Compliance Officers

The DTag prevention engine surfaces deficiencies proactively. Know your gaps before the inspector arrives — not after.

Speak with a compliance specialist.

ComplianceCall demonstrations are conducted by CLIA specialists, not sales staff. We review your current compliance posture before the call so the conversation is immediately relevant to your laboratory.