Research and Science Laboratory Management System

A modular, integrated, and all-inclusive end-to-end Business Process Management (BPM) platform to support all work flows in the labs – Test Methods, LIMS, ELNs, QMS, ECN and Customer Portal

Laboratories performing Scientific Research and Development, Clinical and Preclinical study sample testing, analytical methods development, chemical development can benefit from the out-of-the-box configuration(s) designed to manage the typical material, process, and equipment flows for these teams. Labwise® XD can be used to manage GMP and non-GMP-compliant process flows. You can track equipment and control related activities such as calibration and preventative maintenance, allowing you to reduce operational risk and increase compliance. Features for automated reporting allow you to quickly track nonconformances, such as out-of-specification, by the unit operation.

Labwise XD supports the entire lifecycle of Scientific studies covering research laboratories, clinical, and preclinical study sample testing with full compliance with 21 CFR Part 11 compliance requirements. The overall study process flow is depicted below:

Functionalities of Labwise XD LIMS Platform Scientific and Test Labs

As a flexible BPM tool, Labwise XD Digital Laboratory Information Management System (LIMS) 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 process flow. These modules can connect with legacy and ERP systems as needed.

 

In order to properly manage laboratory business processes, most organizations deploy multiple systems to execute work and track operations such as CAPAs, deviations, process flows, method development, materials, training records, and more.  Functions are often covered by five or more software systems, including LIMS, Electronic Laboratory Notebooks (ELNs), Quality Management Systems (QMS), Electronic Data Capture Systems, Learning Management Systems, and others.  Often these are not integrated and involve manual, paper-driven processes to maintain over time, costing the organization much in time and operational efficiency.

Xybion’s Laboratory Information Management System offers a novel alternative to this approach, enabling organizations to converge on one platform and unify the laboratory operating environment. You can track and control critical business processes that impact the way data is captured, managed, visualized, and reported.  Such business processes are also critical to maintaining regulatory compliance.

A few screenshots of the configurable LIMS application are shown below.  The forms allow dynamic fields, validation rules and a wide variety of field types to support the most complex data entry needs.  Our XD Platform will allow configuration of relevant information of all employees across all the sites, all instruments, methods and offerings, and linked with HR and ERP platform if required.

Labwise XD: LIMS, Compliance and Process Management Modules

Raw Material ManagementIncoming material tracking, Batching/Lot, Batch testing, vendor and source information, Barcode and Location assignment
Sample ManagementSample 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 ManagementAlert Out-of-Specification via email and system validations, OOS Flagging, Record Corrective Action and Preventive Action (CAPA), Cohesive OOS and CAPA Reports
Test & Workflow
Management
Workflow Creation – Define QC Tests, Test sequences, Test parameters, Thresholds, SOP driven, GUI based workflow component
Raw Material, In Process and Finished Product TestingComprehensive modules to track Raw material, In process and Finished goods testing, generate COA and OOS generation, TAT and resource utilization tracking
Reporting and DashboardsStandard 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 managementInventory & vendor management, Instruments tracking, Maintenance and qualification details, Instrument scheduling and utilization tracking
Alerts, Triggers & Notification ManagementConfigurable alerts, threshold values for QC tests, OOS, Inventory Stock levels, Instrument Calibration and Maintenance notices
ComplianceAudit Trails – 21 CFR Part 11, Configure Electronic Signature Validation
AdministrationPersonnel Management, Role-based Access, Customer and Vendor Management, User Logs, Dashboards, and Modular, Customizable Fields and Forms

Labwise XD brings all this functionality together in a single low-code cloud platform from which you can run all of your analytics and reports. This is offered as a SaaS which can be hosted on our AWS cloud or in your own data centers.

A few screenshots of the configurable Digital Lab/LIMS application are shown below.  The forms allow dynamic fields, validation rules and a wide variety of field types to support the most complex data entry needs.  Our XD Platform will allow configuration of relevant information of all employees across all the sites, all instruments, methods and offerings, and can be linked with HR and ERP platform if required.

  • Automated reporting and document control for critical regulated files
  • Enterprise risk reduction and improved regulatory compliance
  • Cost reduction due to IT system consolidation
  • Streamlined compliance monitoring and reporting
  • Business process enablement and enhanced efficiencies
  • Improved visibility into key laboratory workflows and reduction in cycle times