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Molecular Testing

Overview
 
 

Molecular laboratory processing has been advancing and in the Life Sciences field it is becoming more complex. This complexity is evident by Next Generation Sequencing moving beyond the research laboratory into Contract Research Organizations, Public Health, and Specialty Diagnostic testing. At the same time molecular testing is becoming more common in Biotechnology, Food and Beverage and Manufacturing. The distinguishing features of Molecular processes within the laboratory are the increased complexity of multistep protocols and the ability to affect many samples at one time due to the microscopic nature of the molecule. At the same time this increases the need to manage many more samples moving throughout the laboratory, and among many more systems that require integration with multiple instruments.

Life Sciences
 

Contract Research Organizations (CRO)

As CROs are becoming a more practical solution for biotech and pharmaceutical companies to perform their testing and are being more significantly scrutinized by oversight, quality and regulation industries. The FDA has been issuing warning letters to the sponsors and the agencies they are sponsoring due to poor documentation practices. As molecular testing is becoming more prominent in the clinical setting, the need to effectively manage molecular processes is becoming more necessary. Having a LIMS that can manage all molecular workflows along with other laboratory processes provides a means to demonstrate adherence to the regulations. 

 

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 testing

  • 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
Quality Manufacturing
 

Food & Beverage

The food and beverage industry is continuing to expand scientifically and at the same time face more regulatory constraints. There has been an increase in the recalls issued and this may be due to the enforcement of the Food Safety Modernization Act (FSMA). Many recalls are based on the increased capability to perform more effective molecular testing of the products released to the market. As genomic tests are becoming more common for the identification of food borne pathogens, the ability to perform molecular testing, can expands past the inspection laboratories to become part of food and beverage manufacturers quality process prior to the release of product. Thus benefiting the industry by reducing product recalls. And as nutritional science continues to advance, there will be a need to demonstrate the genetic or molecular profile of food and beverage products, again expanding the laboratory’s need to manage molecular processes.

Streamline Day-to-Day Lab Logistics 

  • Direct samples to equipment and workflows based on availability and schedules
  • Interface to automated specimen handling systems and analytical instruments, system-to-system communications via web services, file transfer (text, CSV, HL7, ASCII, etc.), and direct database communications
  • Manage all molecular materials, inventory items and consumables and their associated workflows
  • Manage molecular equipment lists, scheduled maintenance events, calibrations, and QC standards

 

Manage efficient sample and batch testing

  • 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

 

Have Confidence in compliance and best practices

  • STARLIMS has been designed to help your organization comply with a wide range of different regulatory standards of the food and beverage industry including FSMA, HACCP, HARCP, GFSI, GLP, GMP, CODEX 
  • STARLIMS also supports compliance with a wide range of different laboratory regulatory standards, including FDA 21 CFR Part 11 and the EU Annex 11 guidelines, ISO 17025, ASCLD-LAB, CALEA, cGXP and other accreditation standards including newest 18 CAP checklist requirements  

 

Biopharmaceuticals and Other Manufacturing

Besides manufactures who are creating molecular products for use within the industry as well as the life sciences research and clinical fields, molecular processes are becoming more commonplace in the Biopharmaceutical industry and not just during the research and development phase. One of the most complex molecular processes, Next Generation Sequencing (NGS) is turning into an opportune tool for the characterization of biological products, such as viral vaccines, cell lines, final drug products. At the same time instruments that create oligonucleotides are being utilized to create molecular tags used in other molecular assays and more recently to molecularly label manufactured products, for the ultimate identification of product origin. Having a LIMS that can track the manufacturing process from start to finish and include the molecular functionalities provides traceability of the product and source materials and quality metrics. 

Manage efficient sample and batch testing 

  • Support sample and test workflow from start to finish, configure triggers, sample points, re-sample and re-test workflows 
  • Manage molecular protocols, where existing workflows can be used as templates for new protocols, where reference ranges, and reporting requirements can be configured
  • Evaluate sample test results against different sets of specifications and control the progress of the sample or batch through its lifecycle

 

Streamline Day-to-Day Lab Logistics 

  • Direct samples to equipment and workflows based on availability and schedules
  • Interface to automated specimen handling systems and analytical instruments, system-to-system communications via web services, file transfer (text, CSV, HL7, ASCII, etc.), and direct database communications
  • Manage the storage of samples and batches of samples and sample storage locations

 

Choose from available workflows or design your own 

  • Select from pre-existing standard workflows or modify workflows for your needs to perform sequencing, mutation analysis, or expression analysis
  • Create workflows for manufacturing oligonucleotides
  • Share protocol details among workflows

 

Have Confidence in compliance 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, ISO 17025, ASCLD-LAB, CALEA, cGXP and other accreditation standards including newest 18 CAP checklist requirements  
  • Comply with ISO 17025, often the basis for gaining industry recognized accreditations (i.e. National Environmental Laboratory Accreditation Program (NELAP), International Laboratory Accreditation Cooperation (ILAC), American Association for Laboratory Cooperation (A2LA)

 

Manage samples, 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
  • Allow QC standards to be used in multiple workflows
  • Manage the storage of samples and storage locations. Store your samples in hierarchical storage containers and view the contents of each level of the storage hierarchy

 

Integrate with multiple labs

  • Be able to integrate workflows between multiple laboratories providing the ability for an audit trail of one sample across multiple laboratories

The STARLIMS Molecular functionality incorporates seamlessly into your laboratory workflow to allow for a single system to manage the complexity of molecular sample and specimen processing.

 

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