Overview

When a leading manufacturing facility was looking for assistance with implementing a LabVantage LIMS, they knew it would be a complex process. They sought out a team of experienced consultants to provide guidance and expertise on establishing business-approved workflows, gathering and implementing master data in LabVantage LIMS, and developing a project strategy in accordance with their specific needs. After careful consideration, the client chose Astrix for their reputation for successful strategic planning and LabVantage LIMS implementations.

Working closely with the client and their team, Astrix began by developing a detailed plan for implementation that would allow them to quickly and efficiently meet the project timeline. This included gathering relevant data, researching industry best practices, designing custom solutions based on client feedback, and creating comprehensive documentation detailing each step of the implementation process. By leveraging nearly three decades of experience in this field, Astrix was able to deliver an effective solution within the given timeline while guaranteeing satisfactory results upon completion.

Business Challenge

The company was facing a pivotal moment in its growth and needed to replace its legacy in-house-built solutions with a modern commercial off-the-shelf (COTS) solution. To meet this need, the client engaged Astrix to implement LabVantage LIMS to automate and optimize existing workflows and facilitate integration with complex instruments across their business operations.

The project goals identified to address these challenges were as follows:

• Design an architecture that incorporates best-in-class technologies to support the business goals.
• Streamline and optimize current processes into a LabVantage LIMS automated workflow configuration.
• Develop and refine multiple business processes such as batch processing, stability, environmental monitoring, supplier qualification, results reporting, and COA creation.
• Integrate complex instruments such as GCs and HPLCs and systems such as SAP to simplify the overall batch process, sample management, and testing workflows.
• Implement master data such as reagents, instruments, maintenance and calibration events, storage hierarchy, and many other data elements to have one central repository.

Project Approach

A successful LabVantage LIMS deployment requires a comprehensive approach incorporating experienced personnel and proper planning. The technical team must have an individual with multi-level skills who has successfully undertaken large-scale projects. This is essential for the project’s success, as even teams with extensive technical abilities may be unable to deliver satisfactory results if they lack an effective strategy or execution plan. In addition to having the right strategy and personnel in place, it’s essential to ensure that the necessary resources are allocated for the timely completion of all phases of the project, from analysis and design to testing & validation. Furthermore, ensuring that everyone involved is well-versed in LIMS best practices will help ensure that expected outcomes are met. With adequate preparation and resources, organizations can be confident that their LIMS implementation will be successful.

The team proposed by Astrix to address the business challenges of a manufacturing facility was comprised of a business analyst, a technical lead, and informatics engineer who conducted an in-depth analysis of the existing workflows. The technical lead had an advanced understanding of the LabVantage LIMS architecture, development processes and planning, system design, coding style, change management, roll-out strategy, validation protocols, and post-implementation hyper-care. The business analyst worked closely with the team to ensure that all project deliverables aligned with the organization’s business goals and objectives while maximizing their overall return on investment. This involved mapping current processes and forecasting future trends and requirements accordingly.

The project approach and analysis included the following:

• Documentation of user requirements of the end-to-end business process in full detail
• Detailing the sample management and lifecycle processes, including integration with other ERP systems
• Analysis of the batch process for multiple workflows, including raw materials, in-process materials, and finished product elements that make up each workflow
• Development of test analyses with integration to complex instruments to transfer results vs. manual data entry
• Implementation of the project plan to provide a working solution able to be completed within the required timeline

Results Delivered

The project had a clear focus on providing the best-in-class technology solutions to meet the client’s business needs. Therefore, a comprehensive business process analysis was conducted to ensure that the architecture proposed would provide an optimal balance between out-of-the-box features and custom coding. In particular, special attention was paid to avoiding any heavy customization that could add unnecessary complexity or impede future upgrades. Moreover, to ensure maximum efficiency and scalability of the overall system, our team developed several key recommendations tailored specifically to the client’s needs.

The Astrix team worked diligently to ensure the project was delivered on time and within budget, going above and beyond to address the client’s needs. The team successfully implemented the digitization and optimization of workflow processes while allowing flexibility to accommodate the client’s vision.

The results delivered to the customer included the following:

• Comprehensive analysis and detailed assessment of the issues relating to, but not limited to:
  • Batch and sample testing workflows
  • Instrument maintenance and calibrations
  • Reagent manufacturing and lot management
  • Testing assays and specifications
  • Sample plans and sample types
• Creation of detailed master data in the LabVantage LIMS environment
• Development of a LabVantage LIMS implementation plan and strategy
• Integration of instruments to allow for the importation of test results
• Complete URS and FRS requirements documentation along with UAT test scripts for validation

Conclusion

The Astrix consulting team provided invaluable guidance and expertise that enabled the business to establish effective and efficient workflows. This involved gathering, analyzing, and implementing master data into the LabVantage LIMS system with the goal of achieving process automation within the manufacturing environment.

The key takeaways from this case study are:

• How to develop and refine multiple manufacturing-related business processes such as batch processing, stability, environmental monitoring, supplier qualification, reporting of results, and creation of COA.
• Integrating complex instruments, including GCs and HPLCs, with systems such as SAP will simplify the overall batch process, sample management, and testing workflows.
• Implementation of master data such as reagents, instruments, maintenance and calibration events, storage hierarchy, and many other data elements will allow for one centralized data repository for improved QA and traceability.

About Astrix

Astrix is the unrivaled market leader in creating & delivering innovative strategies, solutions, and people to the life science community. Through world-class people, process, and technology, we work with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.