Clinical Laboratory Improvement Amendments (CLIA)

The Clinical Laboratory Improvement Amendments (CLIA) establish quality standards for laboratories conducting tests on human specimens in the United States. These regulations are designed to ensure the accuracy, reliability, and timeliness of test results. CLIA standards apply to all aspects of lab operations, including personnel qualifications, test procedures, quality control, record-keeping, and data integrity.

Seal is able to support your accreditation to CLIA.

1

Accurate Record Keeping

Seal can standardise and automate data capture, ensuring precise documentation of procedures, test results, and instrument calibrations.

2

Data Integrity and Security

Seal is a robust systems with built-in audit trails, electronic signatures, and encryption to ensure that data is secure and traceable.

3

Validation and Compliance Support

Software providers often supply validation packages to assist labs in demonstrating compliance, ensuring the system performs as intended.

4

Quality Control Management

Triggers, and alerts can be set up to automate quality control checks to enable laboratories to meet CLIA’s stringent requirements by flagging deviations or anomalies in real-time.

5

Audit Readiness

Comprehensive reporting and traceability features simplify preparation for CLIA inspections by providing documentation that is organised and easily accessible.

6

Standardised Workflows

Configurable workflows and templates are available ensure that laboratory processes are consistent with CLIA’s operational standards

Seal is designed with regulatory compliance in mind. By leveraging on the Seal Platform, laboratories can streamline their operations, ensures quality and reliability in testing, and traceability for test procedures and results.