Exhibit_B_Workflow_Business_Process.pdf
PDF 82 KB Posted
- Attached to
- PreSolicitation for DCC Laboratory Information Management System Replacement project "LIMSR"
- Solicitation number
- 0000037233
- Issued by
- California
About this file
This document is a detailed scope of work and system requirements specification for a Laboratory Information Management System (LIMS) for cannabis and controlled substance testing. The specification outlines eight primary functional modules: LIMS Login/Access/Dashboard, Sample Receiving, Sample Preparation, Sample Analysis, Data Review, Reporting, Sample Return/Disposal, and Contract Labs coordination. The system must support comprehensive sample management workflows including manual data entry and photo uploads of Certificates of Custody, automated analyst assignment with email notifications, and sample tracking from receipt through disposal. The platform requires capabilities to perform testing for cannabinoids, moisture content, psilocybin/psilocin, foreign material, microbial impurities (Aspergillus, Salmonella, STEC), water activity, heavy metals, pesticides, residual solvents, mycotoxins, terpenoids, vitamin E compounds, pH analysis, and other parameters. Additional requirements include barcode generation, equipment management with preventive maintenance tracking, proficiency and competency testing records, and inventory management for samples, reagents, and consumables.
The system must provide multi-computer and remote login access with robust search functionality tolerant of spelling variations. Key technical requirements include integration with laboratory equipment (HPLC, LC-MS, GC-MS, ICP-MS, qPCR, MALDI-TOF), raw data file upload capabilities, internal report generation with analyst and supervisor review workflows, and final report delivery in PDF format. The platform must track turnaround time from sample receipt to report delivery, manage sample splits and shipping to contract laboratories, calculate available testing capacity based on sample quantity, flag insufficient sample amounts, maintain ISO certification documentation, and generate statistical reports including sample volumes and inventory summaries. The system should identify eLAR format errors and maintain complete audit trails and regulatory compliance records throughout the sample lifecycle.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Exhibit_D_-_Cost_Workbook_DCC_LIMS.xlsx | XLSX spreadsheet | |
| Exhibit_A_Functional_Non-functional_workbook_RFP_2.xlsx | XLSX spreadsheet | |
| DCC_LIMS_RFP_2025-002_Pre-Soliciation_Feedback_Form_Final.xlsx | XLSX spreadsheet | |
| LIMS_2.0.pdf | ||
| Pre_Solicitation_Cover_Page.docx | DOCX document |
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Text version
Manually add/edit sample information
Upload Photos (COCs, Sample description, sample images with packaging)
Upload eLAR or upload sample information through online portal by clients:
Should have ability to identify source of error if eLAR format does not match the required format
2.0 Sample Receiving
Assign analyst and email to analyst
Email to sender:
acknowledge the receipt of the sample
Initiate and maintain email communication to track and provide update
3.0 Sample Preparation
Ability to access all the information by analysts and supervisors
Record additional sample information, samples weight etc
Create LIMS ID and assign method
Create Test Methods: Cannabinoids Moisture Content
Psilocybin/Psilocin (qualitative method) Foreign Material
Microbial Impurities- Aspergillus Microbial Impurities-Salmonella
Microbial Impurities-Shiga Toxin Producing Escherichia coli (STEC)
Water activity Heavy metals
Pesticides Residual Solvents
Mycotoxins Terpenoids
Vitamin E and Vitamin E Acetate pH
Others
Assign equipment and optional ability to connect equipment
Add reagents lots information, ability scan reagents lot to capture all the information.
Ability to flag QA related issue
4.0 Sample Analysis
Assign SOP previous uploaded
Upload relevant SOPs
Upload raw data file from different equipment like HPLC, LC-MS, GC-MS, ICPMS, qPCR, MALTDI-TOF etc
Manually add/edit data
Generate internal report or upload internal report to review by analysts and supervisors
Send email to analysts and Supervisors to notify
5.0 Data Review
Ability to review and edit data by analysts and Supervisors
Notification of approved/peer-reviewed
6.0 Reporting Final review of the data Download report in pdf format
Release report directly from LIMS or manually by email
8.0 Contract Labs
Communicate Contract Labs if applicable
Create shipping label and communicate accordingly
Record remaining sample amount
7.0 Sample Return/
Disposal
Send email to notify sample return or disposal questions
Record information after return or disposal
1.0 LIMS Login
Access/ Dashboard
Sample split and ship to contract labs as needed
Upload photos of new
COC
Update remaining sample amount
Record required input amount for each test
Flag and notify if the insufficient amount of sample received
Should be able to calculate number of tests can be completed based on available sample amount
Inventory management of sample and lab supplies including reagents and consumable
Able to review, download, generate internal report for lab statistcs, # of samples, inventory summary, analysts name
Generate barcode
Manage PM of equipments with notification on due date
Manage Proficiency Test and Competency Test record and timeline
Able to calculate number of possible tests based on available reagents and consumables
User should be able to Login in on multiple computers and remotely
Should be able to search specific records
Searches should be flexible enough to tolerate mistake in spelling, like google search.
Generate Quality Control Reports and have traceability
Maintain regulatory documents related to
ISO certification, audit
Assign analysts
Able to track the inventory status and send notification to assigned individual
The system should track the turnaround time from sample receipt to report delivery and notify to analysts
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