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LIMS/ELN/CDS/Product-Release System

OVERVIEW

In order to address quality issues and improve efficiencies, a leading biotech company planned to implement global, integrated LIMS/ELN/CDS/Product-Release systems for 18 sites (including QC and R&D laboratories). The client did not have large-scale, automated laboratory systems experience to lead this project. They called upon LabAnswer to provide best-in-breed laboratory informatics strategic leadership, management and technical expertise.

BUSINESS CHALLENGES

  • The client had not implemented a fully integrated, global project on this scale before – and originally did not understand all the required project workstreams.
  • The LIMS vendor demonstrated that they could not deliver on their commitments nor meet the deadlines.
  • The client, through the vendor, had outsourced method development for the Lab Method Execution System (ELN) to a company in China which had little to no experience in ELN systems and laboratories. This resulted in inconsistent and sometimes incomplete work.

SOLUTION

LabAnswer has demonstrated our expertise with the complexities of implementing integrated systems in a regulated environment in a multi site project. We have utilized our strategic knowledge, business understanding and technical expertise to manage the vendors, define, develop and lead the various project workstreams to ensure a successful, high quality implementation.

  • LabAnswer provided the client with an approach to large-scale integrated laboratory system projects, identifying all the project workstreams, the various workstream owners, their roles and responsibilities as well as all the major deliverables across each piece of the project. This resulted in the creation of individual teams and project teams for each of the workstreams. This made the project more manageable as each team was able to focus on their part of the project with each of the sites and provide more streamlined and harmonized functionality for the entire project.
  • Because of our previous experience with the vendor, LabAnswer became the liaison between the client and the vendor. We ensured that the client's needs were being clearly articulated, documented and understood by the vendor. LabAnswer had the full lifecycle knowledge to correctly manage the vendor, knowing when to push on the part of the client and when to give leeway and work with the vendor and advise the client on alternative actions.
  • LabAnswer provided project management and domestic technical expertise for this critical function that was in the first stages of development by the vendor.

RESULTS DELIVERED

LabAnswer provided project management, business analysis, and technical expertise for the various workstream teams including Operations Team (including site deployment and data management), LIMS Team, LES (ELN) Team, Empower (CDS) Team, Validation Team and Training Team. With this structure in place, collaboration and communications for the project became much more streamlined which resulted in a cohesive approach to implementing all of the different segments of the project.

Using an upgraded ELN team to take over the development of the ELNs in house to allow the client to have more control of this development and increase the speed and quality in which the 2200 ELN methods could be completed.

LabAnswer has been able to keep the overall project on track as it progresses and changes occur based on stakeholder issues and requirements. LabAnswer was recognized for our outstanding work, ability to motivate both the Project Core team, the individual teams and each of the 18 sites that will be going live in 2011. Our ability to work extremely well with both client and non-client personnel is another reason for the continued success in meeting goals for this project.