The vendor required to provide laboratory information management system replacement (LIMSR) solution to support sample testing of cannabis and cannabis products.
- The solution, among many things:
• Will improve the transfer of chain of custody of the product.
• Input of samples received by the CTLB.
• Processing of the sample through the various stages of testing, and reporting of testing results.
• Support a web front end to submit test sample requests.
• Receive test sample results reports, query records and data fields, interface with CTLB instruments and other systems, linking, accession, and route samples, and run batches.
• Multiple workflows will be replaced by an electronic workflow solution for quality control and quality assurance measures.
- The functional requirements necessary to support the office
• LIMS login access and dashboard
• Sample receiving
• Sample preparation
• Sample analysis
• Data review
• Reporting
• Sample return and disposal
• Contract labs
- LIMS login access and dashboard
• The system will have secure user access with roles and permissions managed by administrators.
• It will include password protection, audit tracking, and allow users to log in from any workstation, including remotely.
• Users will be able to easily navigate the system through menus and screens. Administrators can update system settings and monitor activity.
• The system will track equipment maintenance and user competency records.
• It will also manage inventory of supplies with alerts for low stock and upcoming expirations.
• The system will connect with purchase order and procurement processes.
- Sample receiving
• The system will support electronic and paper test requests, allowing batch entry and linking of requests to samples using barcodes or other tracking methods.
• It will generate unique accession numbers, create barcode labels, and support instrument-specific data for test batches.
• Users will be able to flag sample issues, track chain-of-custody, and record sample conditions such as temperature and humidity.
• The system will also support uploading sample photos, automatically reject samples based on custom rules, and allow follow-up tracking for linked samples (e.g., acute and convalescent).
• It will manage sample-related reminders, hazard screenings, and partial test entries when full data is not yet available.
- Sample analysis
• The system will support both manual entry and automated import of instrument results, including raw data parsing.
• It will integrate with various instruments and allow real-time management of instrument run queues.
- Reporting
• The system will generate a wide range of standard and custom reports, including workload, turnaround time, quality control, quality assurance, test logs, and submitter usage.
• Reports can be scheduled during off-peak hours, exported in standard formats (e.g., .csv, .xlsx), and delivered automatically via email or a submitter portal.
• The system will also track and report on chain-of-custody, CAPA records, and partial batch testing.
- Multiple process workflows
• The system will provide a secure online portal for customers and submitters to enter test requests, track samples, and download reports.
• The system will support quality control tracking, ensure compliance with industry standards, and provide real-time sample status updates for submitters.
• The system will offer advanced search capabilities, enforce data validation and verification, and ensure required fields are completed.
• The system will also manage data archiving, regulatory form uploads, and provide real-time and mobile access to sample status tracking.
• The system will ensure full traceability by linking reagent lots and test batches to results, track qc measures, and automatically handle retests and batch rejections.
• The system will support multi-layered peer and supervisory reviews with audit trails and electronic signatures to maintain quality and compliance.
- Contract Period/Term: 3 years
