HORIZON complies with the Good Automated Laboratory Practices ("GALP," EPA Directive 2185) and all LIMS-related regulatory mandates in the laboratory industries we serve (e.g., NELAC, CLIA, CAP, AIHA, HIPAA/HITECH, SAMHSA). HORIZON is delivered with pre-configured, industry-specific reports, calculations, and login and sample management functions, for example, all of which are readily customizable without modifications to core system code.
Through the Rules Engine, users can configure special data quality control/validation rules that might apply to their internal QA Program Plan, as well as to customer- and program-specific requirements. The data reviewer can view QC data in the context of both sets of criteria, and quickly determine whether to override an exception or apply a qualifier or QA footnote/notice.
If a change to core code is required for regulatory compliance, ChemWare will deliver the enhancement through a point release to all customers under an active Software Maintenance Agreement. In October 2010, for example, new SAMHSA guidelines went into effect for drugs of abuse testing laboratories. ChemWare published a guidance document to help laboratories implement the necessary configuration changes, along with several changes to stored procedures. No changes were necessary to the off-the-shelf drug testing report or drug summary report required by SAMHSA. HORIZON users can access the guidance document and release notes for the v10.2.1 and 10.1.3 product updates through the Download Center.