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.
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