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 (Laboratory Information Management System), 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
For Pre-clinical 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 pre-clinical 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 pre-clinical business process covered by Labwise™ is summarized below, beginning with study start-up, through operations management and study execution, concluding with final data submission.
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 non-conformances, such as out-of-specification, by the unit operation.