Posted on Lab Informatics. 22 June, 2018
In today’s global economy, mergers and acquisitions have become a dominant strategy to improve profitability, maintain competitive edge, and expand services and reach. This practice is common in several industries such as pharmaceutical, biotech, food and beverage, oil and gas, and others. While corporate mergers certainly can provide several benefits for the organizations involved, they can also present significant challenges, not the least of which is harmonization and optimization of the laboratory environment. This often leads to the need to the need for integrating multiple LIMS apps to support a global enterprise.
Scientific organizations that have recently undergone a merger, and oftentimes even those that have not, are frequently in the situation where different labs in different locations are using different LIMS technologies/solutions. This scenario serves to inhibit process efficiency, cross-organization data reporting, regulatory compliance, and can result in high IT demand.
Given the advanced capabilities of modern LIMS, and the competitive advantages gained through establishing digital continuity across the product lifecycle, there is a strong incentive for modern scientific organizations with disparate LIMS to harmonize their laboratory environment by integrating the multiple LIMS into a single system. In this blog, we will discuss best practices for a project of this nature.
Strategic Planning: Workflow Analysis
Migrating multiple LIMS into a single system is a significant challenge and should not be taken lightly. In order to accomplish a laboratory harmonization project in a way that creates significant business value for your organization, strategic planning is essential. A project of this magnitude is a fantastic opportunity to optimize your laboratory environment by aligning laboratory functional needs with the strategic needs of the business. Towards this end, the initial phase of the project should be a thorough workflow and business analysis.
In this phase of the project, meetings and interviews are conducted with key bench-level analysts across the multiple sites to develop a complete and accurate picture of the current-state workflows and systems. Additionally, meetings with the organization’s management team are conducted to flush out the goals and vison for the optimized future-state.
With current-state workflows in hand, the project team creates a model of the optimized future-state workflows. Once the future-state model is created, system functionality is constrained to only those functions bringing business benefit to the customer, and system requirements are extracted and documented.
Strategic Planning: Enterprise Architecture for the Lab
Integration requirements for LIMS projects involving multiple systems and sites include laboratory devices and instruments, as well as enterprise systems that need access to laboratory data. In order to create a fully-integrated laboratory environment, it is critical to design a laboratory informatics architecture that is aligned with business goals, along with a strategic roadmap to deployment.
Enterprise Architecture for the lab should follow a best practice Value Engineering methodology to create a strategy that maximizes value delivery and aligns business requirements, technology and people in your organization. This process begins with interviews with the IT personnel to determine the current-state architecture of the technology (applications, information systems, instruments, etc.) and how it supports the objectives of your business. This current-state assessment looks at functions and security, user-defined and core system entities, workflow events, customization, reports, and instrument and system interfaces.
Next, a future state architecture should be designed that is aligned with business goals utilizing the future-state user and business requirements that were developed in the Business Process Analysis stage discussed earlier. The end result of this process is a practical roadmap to implement the overall strategic vision for the laboratory informatics ecosystem architecture. In some instances, transitional architectures will need to be designed to provide business value in early stages, without having to wait until the full vision is implemented down the road.
LIMS Selection, Implementation and Integration
Whether you choose to harmonize and standardize laboratory operations on a new LIMS or a legacy system, the technical, business and user requirements from the strategic planning phase are utilized to guide the technology selection, implementation and integration process.
When integrating the multiple LIMS into a single system, there are a number of best practice recommendations that should be considered during the implementation phase:
Iterate Your Implementation. For a project of this size and complexity, it is wise to implement the future-state vision in stages, with the first iteration being the minimum viable solution to go into production with. Just because you can do something does not mean it is cost or time effective to do so. Once this minimum solution is operational, users can provide feedback as to the pain points that they are experiencing, and then decisions can be made as to whether it makes sense from a financial and time perspective to customize the system to provide further automation.
Have a Data Migration and Management Strategy. Data migration for a project of this nature can be a significant challenge. Much or all of the static (and sometimes dynamic) legacy data will need to be extracted, translated and loaded into a new location. Depending on the value of the data in question, it can be archived, transferred to a new repository where it can be consulted and used to create reports, or fully migrated into the new system to be actively used in the new LIMS.
Sometimes, data will be left in legacy systems (e.g., data for a clinical trial that is currently in process) that will be decommissioned over time. Questions to ask that help to determine your data migration/management strategy include: What is the best location to store all the different types of legacy data? How are we going to get the critical data out of the legacy system and into the new LIMS? How are we going to harmonize data across multiple sites?
Data management/migration for any informatics implementation almost always turns out to be a much bigger task than one might have imagined, but this is especially true when trying to migrate several legacy systems to a new LIMS. It is therefore important to formulate a Master Data Management/Migration Strategy at the beginning of the project in order to avoid significant time and cost overruns as the project proceeds, as well as minimal disruption to your lab operations during migration activities. Static data should be migrated as early as possible, while dynamic data migration should be done last to make sure the new system contains the most up-to-date data.
Once the data has been migrated, regulatory requirements mandate that it must be validated to make sure it is accurate and has been transferred properly. Even if your company is not in a regulated industry, validating migrated data is important to make sure your data is sound.
Think about Security Early. It is important to fully detail the desired user roles and the permissions associated with each role before you build the system. As with managing the static data aspects of the project, designing and implementing user permission layers can be a bigger task than expected. Waiting until the end of the project to implement a security framework is a recipe for cost and time overruns.
Don’t Go Overboard with Instrument Integration. While instrument integration can have wide-ranging benefits for your laboratory, some instrument integrations can be challenging and cause project delays. It is important to have a master instrument integration plan that details what, why and when instruments are to be integrated and also identifies which instruments are worth integrating. Don’t let your project get bogged down by trying to integrate instruments that do not provide significant ROI.
Designate Appropriate Internal and External Resources for Project Implementation. A variety of different skill sets are necessary to accomplish the strategic planning, configuration, integration and validation required to successfully execute a LIMS migration project. Unforeseen project challenges can also require outside specialists and/or subject matter experts to move the project forward.
Staffing requirements for a LIMS project of this nature can be extremely complex. Several key roles on the project team will likely need to be staffed by the LIMS vendor and/or an external consultant. Significant collaboration between external and internal resources is required for the success of any LIMS migration project.
The bottom line is that it is crucial for organizations to have a highly competent and skilled project team in place, along with a good project communication plan, to ensure project success. Make sure you plan on designated internal resources spending significant time on the project, which means they will be less available for their day jobs.
Avoid Customizations Unless They Are Really Required: Extensive customizations to satisfy requirements can dramatically extended project duration and make your system difficult to maintain, validate and upgrade. Best practice is to examine and understand all the configurable out-of-the-box features of the new LIMS, and utilize as many of these as you can in your implementation to meet your requirements and simplify implementation.
Change Management. The new system will be a failure if no one uses it. Users must be consulted and involved in the requirements development process in order to ensure that they will accept and use a new and unfamiliar system. In addition, change management activities should involve a comprehensive training program for users of the new system.
Scientific organizations that have recently undergone a merger can benefit from harmonizing their laboratory environment by integrating multiple legacy LIMS into a single system. Benefits of doing so include elimination of data siloes, improved process efficiency, simplified IT environment, and enhanced innovation and regulatory compliance. The complexity of such a project, however, makes having a highly competent and skilled project team a necessity.
If you would like to have an initial, no obligations consultation with an Astrix informatics expert to discuss your LIMS migration project or your laboratory informatics strategy, please feel free to contact us.
About The Author
|Jeff Policastro is Vice President of Business Development and Strategy at Astrix, and he is responsible for the commercial growth and market strategy of the Professional Services Division. He has more than two decades of experience in Quality informatics throughout the global life sciences, chemical, and consumer goods industries. He has an extensive track record driving success and delivering value to his client’s projects.|
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