Diagnostics Lab Management System

Unlike a QC test lab, the diagnostics lab runs as a business and not a support function to a manufacturing operation. This creates additional business responsibilities, in addition to all the nuances a typical test lab would have. A diagnostic lab would start with a customer contract process, enable customers to send samples as per the studies or patient needs, operate testing processes within the lab, connect with customers, send reports to customers and invoice them as per the contract. In addition, a better diagnostics lab would constantly provide the sample status to its customers on a real-time basis.

Labwise® XD is a modular, integrated, end-to-end Business Process Management (BPM) and a LIMS platform, uniquely designed to support laboratory workflows.  As a flexible BPM tool, Labwise XD  can be configured to map all of your LIMS requirements to a number of process flows, including material flows, equipment management, deviation management, and more.  Labwise XD modules are organized to follow the business processes of a Laboratory such as Business & Sponsor Management, Laboratory Operation & Execution, and Compliance & Quality Management. These modules can connect with legacy and ERP systems as needed. This is a complete solution to make labs paperless.

Diagnostics lab business situation

The diagnostics services business has competition. In today’s digital world, it is always expected to keep customer interaction simple and provide visibility to customers as real-time basis as possible.

  • Customers very often send samples through the traditional method without having real contact with the diagnostics labs
  • Lab waits for the distributor to deliver a sample and update their system. Very often, no communication to its customers
  • Customers are kept blindsided and it is difficult to know the exact date of testing and delivery
  • Lab instruments and systems differ significantly from lab to lab
  • Data management is local
  • People skill level varies
  • The constant fear of system issues, data privacy issues 

Key Benefits:

  • Single interface to connect and communicate between the diagnostics labs and its customers
  • End-to-end visibility of sample movement
  • Reduction of data entry issues by over 90%
  • Speed up the process. Productivity improvement by over 40%
  • Easy customization of processes as required by customers
  • Seamless digitized  processes to implement changes quickly
  • Improve quality and reduce non-conformance
  • Manage people training, competency and quality documentation in a single compliant environment. The work environment is always compliant
  • Reduction of tester attrition in the digital work environment

Sample diagnostics test steps

  • Sample requests. Generated from a traditional distributor system or manually created
  • Create contracts. Get information from the contracts system
  • Sample receipts, aliquot management and sample label management. Sample connection to a contract/ study protocol
  • Reagent preparation and management
  • Schedule test instruments
  • Execution of tests
  • Calculate test results as per the protocol
  • Data entry and data management
  • Creation of Certificate of Analysis (CoA)
  • Notify the requestors
  • Stakeholder communications

The system view of an illustrative diagnostics test workflow

Key solution components

Raw Material Management Incoming material tracking, batching/lot, batch testing, vendor and source information, barcode and location assignment
Sample Management

Sample Accessioning – Sample metadata, manual/auto IDs, batch import

Sample Tracking – Storage containers and location tracking, management, genealogy, fractioning and pooling, usage tracking

QC, OOS & CAPA Management Out-of-Specification alert via email and system validations, OOS flagging, record Corrective and Preventive Action (CAPA), Cohesive OOS and CAPA reports
Test & Workflow
Workflow Creation – Define QC tests, test sequences, test parameters, thresholds, SOP driven, GUI based workflow component
Raw Material, In process and Finished Product Testing Comprehensive modules to track raw material, in process and finished goods testing, generate COA and OOS generation, TAT and resource utilization tracking
Reporting and Dashboards Standard Reports & Custom Reports – COA and OOS reports, configurable templates, canned and Ad-hoc reports, various reporting formats- text, tables, and charts
Inventory, Instruments and Resource Management Inventory & vendor management, instruments tracking, maintenance and qualification details, instrument scheduling and utilization tracking
Alerts, Triggers & Notification Management Configurable alerts, threshold values for QC tests, OOS, inventory stock levels, instrument calibration and maintenance notices
Compliance Audit Trails – 21 CFR Part 11, configure electronic signature validation
Administration Personnel management, role-based access, customer and vendor management, user logs, dashboards, modular, customizable fields and forms

Other required solution components are built into the Labwise XD Platform

Most traditional LIMS and ELN provides the core functionalities and requires additional IT systems or significant manual processes to ensure other important business aspects such as documentation, deviation management, CAPA, audits, and people competency. Xybion Lab Management Solution is a one-stop platform-based solution to provide the core and additional required functions.