Digital Quality Control Lab Management System ( QC LIMS )

On average, a QC lab test has over 1000 data elements to be captured and analyzed to test a product. Most lab process steps are executed manually. Labs across various sites and countries follow non-standard processes. Data creation and management is disjointed environment creates a very high risk of data integrity risk.

Xybion Digital Lab is a modular, integrated, end-to-end Business Process Management (BPM) platform, uniquely designed to support laboratory workflows.  As a flexible BPM tool, Digital Lab can be configured to map to a number of process flows, including material flows, equipment management, deviation management, and more.  Xybion’s Digital Lab modules are organized to follow the business processes 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.

QC lab business situation

Manufacturing organizations across the globe are constantly challenged with the QC lab operations due to ever-changing regulatory demands, non-standard processes, manual operations, lack of confidence in data integrity and low qualified bandwidth availability. The situation can be changed significantly through the digital lab solution empowered by modern, smart, low-code Xybion digital platform.

  • Multiple QC labs with varied processes
  • 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:

  • Lab tester productivity improvement as high as 43%
  • Reduction of data entry issues by over 90%
  • Speed up the process. Possibility of reduction of product release time from 6 days to 4 hrs
  • Seamless digitized e2e processes to implement changes quickly
  • Improve quality and reduce non-conformances
  • 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 QC test steps

  • Sample requests. Generated from an ERP system or manually created
  • Sample aliquot management and sample label management
  • Reagent preparation and management
  • Execution of QC tests
  • Data entry and data management
  • Creation of certificate of analysis (CoA)
  • Notify the requestors. CoA submission through ERP if generated from there
  • Stakeholder communications

The System view of an illustrative QC 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 Alert Out-of-Specification via e-mail and system validations, OOS Flagging, Record Corrective Action 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-in 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 one stop platform-based solution to provide the core and additional required solutions.