Introduction:
Scispot enhances lab operations with robust QC checks, equipment maintenance, inventory management, and comprehensive report generation. Our system ensures data integrity, compliance, and efficiency, making it perfect for molecular diagnostic companies and research labs.
Scispot enables the segregation of research and clinical workflows, automates maintenance schedules, tracks inventory expiry, integrates SSO for secure access, and generates detailed reports. These features streamline project management, boost security, ensure regulatory compliance, and provide valuable insights through automated reporting.
This article explores how Scispot can meet your lab's needs, providing a clear understanding of our system's capabilities.
QC Checks at the Pre-Analytical Stage:
We understand the critical importance of ensuring data integrity and compliance at every stage of your processes, particularly at the pre-analytical stage. This stage involves sample collection, identification, transport, and preparation. Below, we outline how Scispot can meet your requirements and provide confidence in our system’s capabilities.
Automated Data Flagging
A. Missing Identifiers and Incomplete Metadata:
Automatic Flagging: Scispot automatically flags data if there are any missing or incomplete identifiers or metadata that are prerequisites for proceeding to the next steps.
Flagged Data Examples:
Missing Sample ID
Incomplete Patient Metadata
Required fields not filled
B. Scheduled Maintenance and Calibration:
Automatic Scheduling: Scispot automatically schedules maintenance and calibration activities based on predefined intervals.
Alerts for Upcoming Maintenance: The system sends alerts for equipment due for maintenance or calibration, ensuring timely action.
Flagged Equipment Examples:
Flow Cytometer due for calibration on [Date]
PCR Machine scheduled for maintenance on [Date]
C. Tracking Expiry Dates:
Automatic Expiry Tracking: Scispot tracks the expiry dates of all inventory items and automatically flags those nearing expiry.
Alerts for Expiring Inventory: The system sends alerts when inventory items are close to their expiration dates, allowing for timely replenishment.
Flagged Inventory Examples:
Reagent A expiring on [Date]
Antibody B expiring on [Date]
D. Notification System (Real-Time Notifications):
QC Team Alerts: When data is flagged, respective QC team members receive real-time notifications. This allows them to review and address the issues promptly.
Equipment Manager Alerts: When maintenance or calibration is due, respective QC managers receive real-time notifications.
Inventory Manager Alerts: When inventory items are nearing expiry, respective QC managers receive real-time notifications.
Customizable Alerts: Notifications can be customized to alert specific team members based on the flag type and the project.
E. Handling Specific Situations:
Blocking Workflow Progression:
For critical equipment maintenance or expired inventory, the system will block workflow progression until the issue is resolved.
Example: If a critical piece of equipment is due for calibration, the workflow will halt, and the QC Manager will be notified to resolve the issue before proceeding.
Allowing Workflow Progression with Warnings:
For non-critical maintenance or inventory nearing expiry, the system can allow the workflow to proceed with warnings, once the information is being triaged by the QC manager.
Example: If a non-critical reagent is nearing expiry, the system will flag it, notify the inventory manager, and allow the workflow to continue with a note.
Post-Analytical QC Check:
Ensuring data accuracy and integrity after analysis is crucial before generating and releasing test reports to clients. Scispot provides a comprehensive system for post-analytical QC checks to resolve all issues and ensure samples meet QC criteria.
A. Templates for Instrument-Generated Data:
Examples of Supported Instruments: Mass Spec, Liquid Handler, Plate Reader
QC Check Options: Built-in templates for processing and verifying instrument data.
B. Mass Spec Analysis Example:
Data Handling: Import data from Mass Spec, transform it, subtract the blank from the analyte peak, and calculate the Signal/Noise Ratio.
QC Criteria: The system checks calculated values against defined QC reference ranges.
Flagging Outliers: If any values fall outside the QC reference range, the system flags them and notifies the respective QC team member.
Triage Process: QC team members can review flagged data, resolve issues, and determine if it is okay to proceed while missing information is being triaged.
C. 96-Well Plate Sample Management:
Individual Sample QC: If a sample in a 96-well plate fails QC, it can be rerun without affecting the rest of the samples.
Rerun History: The rerun history is logged for traceability and compliance.
D. Ability to view the status of every order (samples)
AI Dashboards: Samples can be tracked through AI-powered dashboards, providing real-time updates and insights.
Visibility and Control: Enhance visibility and control over sample status and QC checks through intuitive dashboards.
Data Segregation Between Research and CLIA Workflows:
A. Dedicated Labspaces
Scispot allows you to create separate Labspaces for different types of workflows. This ensures that data from research (R&D) and clinical (CLIA) workflows remain segregated, maintaining compliance and integrity.
R&D Labspaces:
Designed for flexible and innovative research activities.
Allows for rapid changes and iterations in experimental setups.
Example Labspaces: "Genomic Research Lab," "Protein Analysis Sub-Project."
CLIA Labspaces:
Specifically designed to meet stringent regulatory requirements.
Includes features such as audit trails, version control, and validation protocols to ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP).
Example Labspaces: "CLIA Certified Diagnostic Lab."
B. Role-Based Access Control
Scispot's robust role-based access control system ensures that team members only have access to data relevant to their roles and projects.
Assign Roles and Permissions:
Define specific roles such as Principal Investigator, Research Assistant, Lab Director, Clinical Scientist, and Quality Control Officer.
Grant selective access to folders and resources within Labspaces based on these roles.
Ensure that R&D team members cannot access CLIA data, and vice versa.
Team | Labspace | Role | Access Level | Workflow Type |
R&D Team | Genomic Research Lab | Principal Investigator | Full Access | Non-GXP (Flexible) |
|
| Research Assistant | Limited Access | Non-GXP (Flexible) |
CLIA Team | Diagnostic Lab | Lab Director | Full Access | GXP (Strict) |
|
| Clinical Scientist | Limited Access | GXP (Strict) |
|
| Quality Control Officer | Audit Access | GXP (Strict) |
C. Workflow Automation
Scispot enables you to create and customize workflows tailored to the specific needs of R&D and CLIA environments:
R&D Workflows:
Utilize flexible protocols and templates.
Allow rapid updates and changes as required by the research process.
CLIA Workflows:
Follow validated and standardized protocols.
Maintain strict compliance with regulatory standards.
Implement electronic signatures and validation steps to ensure data integrity.
Single Sign-On (SSO) Integration:
Scispot integrates with Single Sign-On (SSO) systems to streamline user authentication and enhance security. This ensures that individual logins are managed efficiently, and access is controlled based on user roles. Scispot supports SSO with Microsoft and Google.
Simplified User Authentication:
Users can log in using their institutional credentials, reducing the need for multiple passwords and enhancing security.
Ensures that only authorized personnel have access to specific Labspaces and data.
Enhanced Security:
SSO integration minimizes the risk of unauthorized access.
Centralized user management allows for easy onboarding and offboarding of team members.
Sample tracking through barcodes:
Scispot enables users to print labels with 1D barcodes for efficient sample/inventory tracking. These barcodes can be scanned using integrated barcode scanners, allowing seamless identification within the system. Once scanned, the system automatically maps the barcode to the respective sample, displaying its location, quantity, or current workflow stage. This integration ensures precise sample management and enhances workflow efficiency in your lab.
Custom Reporting Features
A. End-to-End Automated Report Creation:
Automated Reports: The system supports end-to-end automated report creation tailored to your use case.
Preferred Templates: Utilize your specified templates and reference ranges for analysis.
Adherence to QC Rules: Reports are generated while adhering to your QC rules.
B. Handling Holds and QC Checks:
Pre-Analytical Hold: Samples with missing or incomplete pre-analytical data are flagged and held until resolved.
Analytical Hold: Samples that fail QC checks during analysis are flagged and held for review.
Post-Analytical Hold: Samples cannot be reported until all pre/post-analytical issues are resolved.
C. Traceability of Test Reports:
Scispot ensures traceability for all test reports
Each event and the corresponding test report are logged and accessible within the LIMS, ensuring full traceability and compliance.
D. Status Column for Reporting:
Custom Reports: We can configure custom reports based on your data type.
Status Updates: We offer a 'Status' column, that allows users to update the status of sample processing. Reports are generated once the QC team updates/approves the status and results.
Conclusion
Scispot is designed to streamline your lab operations through comprehensive QC checks, precise data management, and customizable reporting. Our robust access control, barcode integration, and tailored solutions ensure your team can work efficiently and securely. We are committed to supporting your lab’s success and are here to discuss any specific needs you may have. Reach out to us at [email protected]!