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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 supports CLIA accreditation through:
  1. Accurate Record Keeping
Seal can standardise and automate data capture, ensuring precise documentation of procedures, test results, and instrument calibrations.
  1. Data Integrity and Security
Seal is a robust system with built-in audit trails, electronic signatures, and encryption to ensure that data is secure and traceable.
  1. Validation and Compliance Support
Seal provides validation packages to help laboratories demonstrate compliance and confirm the system performs as intended.
  1. 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.
  1. Audit Readiness
Comprehensive reporting and traceability features simplify preparation for CLIA inspections by providing documentation that is organised and easily accessible.
  1. Standardised Workflows
Configurable workflows and templates ensure that laboratory processes are consistent with CLIA’s operational standards Seal is designed with regulatory compliance in mind. Laboratories using Seal can streamline operations while maintaining quality, reliability, and full traceability for test procedures and results.