Labwise-The total BPM Solution for Laboratories
Labwise is a modular, integrated, end-to-end business process management (BPM) platform, uniquely designed to support laboratory workflows. Through a configurable business process workflow engine, you can manage multiple aspects of your operation, from employee training to equipment management to deviations tracking and general process oversight. As an enterprise-ready solution, Labwise provides full lifecycle support for integrating critical, regulated workflow processes in a typical laboratory environment. In addition, the platform provides functions to support 21 CFR Part 11, including electronic signatures, records archival, and reporting. By automating current processes, Labwise can help you reduce or virtually eliminate paper-based tracking systems.
Labwise unifies the laboratory environment by providing seamless integration with electronic data capture and data warehousing systems, such as Xybion’s Pristima and Savante solutions. This promotes continuous improvement by enabling companies to track critical business processes, such as deviation/CAPA handling, material flows, equipment management, and more – alongside data capture and analytics workflows.
Xybion offers out-of-the-box, pre-configured workflows designed to support specific laboratory types, such as Labwise for Preclinical (GLP/Non-GLP) and Labwise for Pharmaceutical Development (GMP/Non-GMP) laboratories. As a highly extensible platform, Labwise can also be configured to map to your custom laboratory needs, together with Xybion’s expert professional services team.
The Labwise platform offers a flexible laboratory operations and business process management environment containing several modules, shown below. Organizations can choose to implement only the functionality they need, enabling a cost-effective implementation that is ready to scale as your needs grow.
Process Flows Supported by Labwise
As a flexible BPM tool, Labwise can be configured to map to a number of process flows, including material flows, animal management, equipment management, deviation management, and more.
The Business Case for Labwise
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.
Labwise offers a novel alternative to this approach, enabling organizations to converge on one platform and unify the laboratory operating environment. With Labwise, 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.
With increasingly complex operating environments involving multiple partners and disparate geographic locations, it is more important than ever for high performing organizations to have a centralized repository to track business processes and monitor quality. Other benefits include:
- 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
Labwise for Preclinical Laboratories (GLP and Non-GLP)
Life science companies operating in both GLP and non-GLP environments can leverage integration with the Pristima Suite and unify preclinical data capture and process compliance workflows. This integration allows organizations to manage study operations, business processes, controlled documents, non-conformance/deviations, and more, all within one seamless platform.
The typical preclinical business process covered by Labwise is summarized below, beginning with study start-up, through operations management and study execution, concluding with final data submission.
Labwise for Pharmaceutical Development (GMP and Non-GMP)
Laboratories performing pharmaceutical development functions, such as analytical development, method development, chemical development, and formulation 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 can be used to manage GMP and non-GMP formulations, methods, and related 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 unit operation. In addition, you can manage, control, and approve critical documents, such as SOPs, Material Safety Data Sheets (MSDS) documents, and Certificate of Analysis (C of A).
Key Features of Labwise
- Link scientific data to critical controlled documents. Seamless integration allows users to access key documents such as SOPs, Material Safety Data Sheets (MSDS) documents, and Certificate of Analysis (C of A) documents just in time.
- Manage Deviations and Corrective Actions/Preventive Actions (CAPA). The system delivers workflow processes that enable proactive management of Corrective Actions / Preventive Actions in a timely manner.
- Manage controlled documents The system provides out-of the-box capabilities for full versioning, document approvals, PDF rendering, document training records, connections to other CMIS compliant systems, and more.
- Manage business processes, including task notifications, powerful queries, and reports to users.
- Conduct audits and track non-conformance. A robust feature set empowers your team to plan, prepare, and execute internal and external audits and accomplish day-to-day operational tasks related to all non-conformances.
- Streamline compliance monitoring and reporting.
- Easy-to-configure dashboards, scorecards and reports allow you to track compliance monitoring and report against key compliance performance indicators.