Public Health

Public Health and Specialty Diagnostic Laboratories

Molecular testing is becoming more affordable and now more mainstream. Even in the Public Health arena molecular assays are becoming the norm, and in the Clinical Diagnostic setting Next Generation Sequencing (NGS) is becoming more prominent for disease profiling. The proliferation of complex molecular testing such as that of NGS in clinical laboratories has led to new requirements and guidelines to be issued by CAP, CLIA, and ACMG. These cover the need for assay validation and the management of sample processing, the data obtained during testing and the release and dissemination of results. CAP and CLIA inspectors are starting to familiarize themselves with these guidelines and the recertification process will become more tenuous. Laboratories that have implemented the new requirements and recommendations reduce the risk of having deficiencies found during inspections. Having a LIMS that can demonstrate effective management of these high complexity molecular processes, contributes to the growth and validity of the laboratory.

Manage Efficient Sample And Batch

• Manage molecular protocols, where existing workflows can be used as templates for new protocols, where reference ranges, triggers, reflexes and reporting requirements can be configured
• Support sample and test workflow from start to finish, configure triggers, sample points, re-sample and re-test workflows
• Allow for batch adjustment and multiple batch templates to be used in one complex workflow
• Evaluate sample test results against different sets of specifications and control the progress of the sample or batch through its lifecycle
• Generate worksheet/list, result calculations, and result specifications.
• Link to bioinformatics systems (third-party systems) (internal or external) for data analysis, prior to result reporting

Streamline Day-to-Day Lab Logistics

• Direct samples to equipment and workflows based on availability, staff certifications and schedules
• Interface to automated specimen handling systems and analytical instruments via system-to-system communications using a wide variety of protocols such as web services, file transfer (text, CSV, HL7, ASCII, etc.), and direct database communications
• Manage result reporting for single samples moving through multiple laboratories and workflows
• Manage the storage of samples sample storage locations

Manage Sample Materials And Equipment

• Manage all molecular materials, inventory items and consumables and their associated workflows
• Manage molecular equipment lists, scheduled maintenance events, calibrations, and QC standards
• Store your samples in hierarchical storage containers and view the contents at each level of the storage hierarchy

Have Confidence In Compliance To Regulatory Mandates And Best Practices

• STARLIMS has been designed to help your organization comply with a wide range of different laboratory regulatory standards including FDA 21 CFR Part 11 and the EU Annex 11 guidelines, GLP, APHL, CLIA, CAP and other accreditation standards