Compliance: Quality, Integrity, and Accuracy

LabLynx ELab LIMS can be configured around your processes to ensure your lab is compliant with many standards and regulated criteria. The LabLynx LIMS has the necessary features and capabilities to support the testing and calibration activities of the laboratory and to ensure that the results of these activities are accurate, reliable, and conform to regulatory requirements.

Laboratory Compliance: Regulatory Agencies, Requirements, and Standards

LabLynx has assisted our clients with laboratory compliance, meeting an array of guidelines, best practices, standards, and regulatory requirements. Below are just a few examples:

21 CFR Part 11

This US regulation establishes the requirements for electronic records and electronic signatures. A laboratory that is 21 CFR Part 11-compliant has demonstrated that it follows these requirements for electronic recordkeeping and signature processes.

40 CFR Part 3

This US regulation establishes the cross-media reporting requirements to the Environmental Protection Agency (EPA) by laboratories that analyze environmental samples. A laboratory that is 40 CFR Part 3-compliant has demonstrated that it meets these requirements for its environmental analysis and reporting activities.

CAP (College of American Pathologists)

CAP compliance is recognized as the gold standard for laboratory accreditation by the Centers for Medicare and Medicaid Services (CMS) and other regulatory agencies. A laboratory that is CAP-accredited performs testing on humans or animals using the methodologies and clinical applications within the expertise of the program.

CLIA (Clinical Laboratory Improvement Amendments)

This US regulation establishes standards for the quality and accuracy of clinical laboratory testing. A laboratory that is CLIA-compliant has demonstrated that it meets these standards for the quality and accuracy of its clinical laboratory testing.

FDA (Food and Drug Administration)

This federal agency is responsible for regulating the safety and effectiveness of food, drugs, medical devices, and other products in the United States. A laboratory that is FDA-compliant has met the standards and requirements set by the FDA for the production, testing, and distribution of these products.

GALP (Good Agricultural Laboratory Practices)

These guidelines and principles are used to ensure the quality and integrity of laboratory research in the agricultural sector. A laboratory that is GALP-compliant has demonstrated that it follows these guidelines and principles in its agricultural research activities.

GLP (Good Laboratory Practices)

These guidelines and principles are used to ensure the quality and integrity of laboratory research. A laboratory that is GLP-compliant has demonstrated that it follows these guidelines and principles in its research activities.

HIPAA (Health Insurance Portability and Accountability Act)

This US law establishes standards for the protection of personal health information. A laboratory that is HIPAA-compliant has demonstrated that it follows these standards for the protection of personal health information.

ISO/IEC 17025

This international standard addresses the general competence requirements for the competence, impartiality, and consistent operation of sampling, testing, and calibration laboratories. A laboratory that is ISO/IEC 17025-compliant has demonstrated that it has the necessary skills, knowledge, and resources to provide accurate and reliable testing, sampling, and/or calibration results.

NIH (National Institutes of Health)

This federal agency is responsible for conducting and supporting medical research in the United States. A laboratory that is NIH-compliant has met the standards and requirements set by the NIH for the conduct of research activities.

LabLynx Compliance Consulting

The LabLynx ELab LIMS is a compliant solution designed to meet the regulatory standards and requirements that are relevant to your lab’s specific industry.

LabLynx can also provide compliance consulting services, which would involve working with your laboratory personnel to develop and implement strategies to achieve and maintain compliance with regulatory standards and requirements. This may include developing and implementing standard operating procedures (SOPs), reviewing and updating your business policies and laboratory procedures, and providing guidance on how to use the LabLynx LIMS to meet regulatory requirements.

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Compliance is vital to your laboratory business and reflects the quality, integrity, and accuracy of the work your lab team produces. Our compliance services are just one important component of an overall package of LIMS software solutions and services to help your laboratory exceed its operational objectives while remaining lean and relevant in a highly competitive market. See how LabLynx and the LabLynx ELab LIMS can help your lab meet the guidelines and regulations in your laboratory industry.

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