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Implementation of Enterprise LES/ELN, LIMS & Chromatography Data System (CDS)

OVERVIEW

The LES/ELN, LIMS, and CDS are to be deployed to 17 different sites (12 for the LES/ELN) in the US and Europe. The deployment includes ELN methods and templates, interfaces to both instruments as well as adjacent Enterprise Systems, LIMS with client specific customizations and configurations, third party application interfaces and a custom Product Release Information management System.

BUSINESS CHALLENGES

  • Enhance the existing Product Data management System (PDMS) across several diverse sites
  • Implement LES/ELN, LIMS, and CDS systems to manage the collection, processing, storage, retrieval, and analysis of information generated at the laboratories
  • Improve the reliability of sampling processes
  • Support compliance with domestic and international regulations and industry standards
  • Provide comprehensive reporting, monitoring, and analysis capabilities

SOLUTION

This program represents a large scale, simultaneous global configuration and deployment of a LES/ELN, LIMS, and CDS solution. The project included the Design/Development, Validation, and Deployment phases. During the Development phase of the project, the LES/ELN, LIMS, and CDS teams worked with seventeen sites to develop system designs and configurations, reports, method objects, and harmonization procedures to minimize customizations to the COTS applications. All configurations and customizations were documented as required by the client’s document management procedures.

The LES/ELN team was tasked with gathering requirements, developing design and configuration, and building the ELN methods. The LES/ELN application being deployed was in the vendor’s beta phase. Limitations of the application and a decentralized method development approach employed by the client added to the complexity. LabAnswer worked closely with both the vendor and client to quickly resolve issues.

The LIMS team was tasked with the design, configuration, and customization of the COTS LIMS application as well as the design and oversight of the development of three custom modules delivered by the vendor. The LIMS was considered the centerpiece of the project as all interfaces and data exchange ran through the LIMS. The number of sites involved with this program and the diversity of the business processes covered within the R&D, manufacturing, packaging, and stability areas of each of the sites added to the complexity of this workstream.

The LabAnswer Project Manager for the LIMS and ELN/LES team fulfilled the role of liaison between the client and the vendor. The PM was instrumental in prioritizing issue resolution and customization efforts with the vendor to keep the LIMS development and configuration tasks on time. The team was able to meet their completion date for the delivery of the latest version of the application.

RESULTS DELIVERED

  • The ELN team was able to meet the target deployment dates for the sites.
  • The LabAnswer PM for the ELN team was able to keep the vendor prioritized in meeting delivery dates for issue resolution and delivery of updates.
  • LabAnswer was also called in to "rescue" an initial ELN method load that was off-shored by the client. This initial off-shore effort produced methods that were unusable.
  • LabAnswer responded by correcting the methods and getting the conversion effort back on track and building 2,100 methods within months.
  • The LabAnswer Training Project Manager directed his team to meet the timelines for the availability of the Users Manuals and Training program.

LabAnswer is unique in our ability to manage and execute a deployment of this size, and to provide a vendor-independent perspective. We have the personnel, processes, and expertise to manage the rollout of laboratory enterprise systems. The integration of LIMS, ELN, and CDS systems has both a high level of complexity and a high value to the business. LabAnswer has the experience and capability to integrate these systems across the enterprise to produce an effective scientific management system while promoting collaboration across geographic and functional boundaries.