Quality Records Management

Nearly all HORIZON user laboratories are accredited or regulated by CAP, CLIA, NELAC, A2LA, SAMHSA, ISO-17025, and/or various state and federal government agencies. Maintaining compliance with quality control and regulatory standards requires a LIMS that is capable of managing documentation (e.g., SOPs, training records/certifications, initial demonstrations of capability/proficiency), audit trails, system access/security, electronic records, and electronic signatures. HORIZON LIMS plays a major role in enforcing laboratory compliance with these standards.

HORIZON LIMS has also been independently validated for compliance with the FDA’s 40 CFR Part 11 standards for electronic record keeping and electronic signatures, and complies with all HIPAA/HITECH regulations relating the confidentiality of personally-identifiable information (primarily applicable to patient-related information in a clinical LIMS implementation).

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