Generally speaking, Laboratory Information Management System (LIMS) software from any major laboratory informatics vendor can successfully automate and manage your labs, adding great value to your laboratory operations and organization. The LIMS product you have chosen (or are likely to choose) will have been used by many other companies and laboratories. But your implementation is specialized – with aspects unique to your own environment, company, and laboratory processes.
In this article we will discuss how the right Project Manager can help ensure that your laboratory’s specialized needs are met. What should be considered in choosing a LIMS Project Manager (PM) to ensure your LIMS project is successful? What questions should I ask him/her?
Each LIMS Implementation is different
First, let’s do a quick review of what makes LIMS and LIMS implementation projects so complex. How laboratories operate and conduct their work is much less standardized than, say, warehousing operations or financial accounting. This high diversity of processes within laboratories adds complexity to both the LIMS itself, and the challenges in achieving a successful LIMS implementation. Here are some of those factors:
- Industry – LIMS support diverse industries such as pharmaceuticals, forensics, food, mining, environmental industries, petroleum, manufacturing, and others. Each industry has specialized needs and terminology.
- Regulatory environment varies with industry and domain often leading to differing requirements within each segment such as: chain of custody, electronic signatures, ISO compliance, FDA/GxP regulations, ISO certification, or CLIA needs.
- Terminology used in your laboratory – this is not standard across laboratories, nor industries
- Internal/external – Laboratories may be internal (i.e. supporting your own company processes), or external (i.e. the lab performs contracted testing for other companies).
- The size of the laboratory and what types of instrumentation and analyses are used vary widely – from inorganic to organic to biological to genomic, and from manual to automated techniques.
- Physical factors such as; multiple laboratory sites, buildings, or rooms.
- Experience levels with automation – of laboratory chemists, biologists, specialists, and technicians
- Company culture such as openness to change and training approaches
The LIMS Project Manager
As you can see, LIMS implementations are complex in nature – with many factors to be managed in order to achieve success. Unless your project is very simple and short-lived, a LIMS Project Manager is therefore critical for the success of the project. The LIMS Project Manager is the person who understands and synthesizes the many factors that, in combination, assemble your project into a symphony of moving parts that will deliver productive, working lab management software, trained staff, and new procedures — all while aiming to deliver on time and on budget.
It is not uncommon, unfortunately, to see situations where customers are on their second or third attempt to successfully implement their LIMS systems. A common thread in these situations is that a qualified LIMS Project Manager was not identified, nor employed during the earlier LIMS implementation attempts.
Specific qualifications to look for in a LIMS Project Manager include:
- Traditional project management skills and experience – familiarity with project management concepts, creating and maintaining schedules, managing budget, coordinating dependent tasks
- LIMS expertise – expertise in the specific LIMS that you are implementing.
- LIMS implementation experience – successful track record of implementing LIMS in a similar environment
- Communication skills – ability to run meetings, work 1 on 1 with key staff, talk at all levels from technician to executive, and deliver regular status reports
- Management skills – handle conflict, resolve differences, bring individuals to a common conclusion or decision, and provide guidance for a Steering Committee
- Domain skills – Understanding and familiarity with laboratory operations, scientific/analytical techniques, and what the data generated will be used for
- Regulatory knowledge (depending upon environment) such as CLIA, HIPPA, GxP, 21CFR Part 11, computer validation, ISO 9000/9001/17025, etc.
- CSV knowledge – knowledge of software testing, test script preparation, and documentation, if the LIMS is being implemented in a regulated environment requiring Computer Systems Validation (CSV)
→ Related Reading: Reducing the Unknowns: The Value of Lab Informatics Project Managers
How do I Identify the LIMS Project Manager?
When choosing your LIMS Project Manager, it is critical that they have the necessary and required skill sets that will maximize your LIMS project success rate. The LIMS Project Manager can be obtained from one of three general sources:
- Internally – If the organization embarking upon a LIMS implementation project has internal Project Managers with the experience, skills, and knowledge of Project Management, the specific LIMS being implemented, the laboratory domain, and the regulatory (if any) requirements, then an internal PM can be a good solution.
- Externally, from software vendor – When a suitable internal candidate is not available, then external resources should be sought. LIMS software vendors often offer Project Managers who do an excellent job of managing the software development/configuration being done by the vendor’s resources. However, it is rare for a vendor PM to take a broader, more holistic approach to managing the project and aiding you in attaining your company’s long-term strategy.
- Externally, from independent vendor – LIMS-specific Project Managers from Independent consultancies, experienced in LIMS implementations, will typically deliver additional value beyond that of the software vendor Project Managers. An independent LIMS project manager hired for the company’s LIMS project will ultimately be solely oriented towards the success of the LIMS project and the company strategy. Additionally, they are often more experienced than internal or vendor-supplied Project Managers, having been afforded the opportunity to manage a wide variety of LIMS implementation projects. As such, they frequently have a much broader, holistic view of many key areas – including ensuring the system meets long-term business strategy, managing internal and contractor team dynamics, understanding various regulatory approaches, and delivery of required training and documentation using appropriate methodologies
What Questions Should I Ask the LIMS Project Manager?
No matter what the source of the candidate LIMS Project Manager, ask him/her specific questions about their experience and interpretation of your own company challenges and constraints. Use their answers to your questions to aid in choosing the right Project Manager, and for preparing the laboratory for the LIMS implementation, upgrade or enhancement. Some good questions include:
- What is your experience with laboratory systems?
- The excellent LIMS Project Manager will have experience with LIMS systems in general and even your specific LIMS in particular, including multiple implementations in a variety of circumstances and domains. This experience will enable him/her to offer suggestions and best practices that they have garnered over their career as well as structure your project realistically with maximum chances for success.
- What are the common pitfalls that I might encounter? How will we mitigate those risks?
- Your Project Manager should be able to answer these questions by offering valuable insights and potential solutions. They will have seen many different implementations and their associated challenges.
- What are the advantages and disadvantages of a “Big Bang” versus a Phased approach?
- There are tradeoffs for doing your project all at once versus breaking it up into multiple parts (i.e. phases) and deployments. An experienced LIMS Project Manager can compare and contrast these approaches to help you select and execute the best LIMS implementation strategy for your organization.
- What changes to my operations should I expect?
- Many laboratories performing first-time LIMS implementations often expect to “automate exactly what we do now” which may require extensive customization of your LIMS. Your LIMS Project Manager should be able to suggest common or best-case approaches to operational changes to improve efficiencies and maximize the beneficial value of the new or upgraded system.
- What do I need to tell my staff? How should I prepare them for this upcoming change?
- Your Project Manager should will have the breadth to look beyond only the technical side of the project to the “soft skills” side. The new software may work as designed, but the impact on laboratory staff and their stakeholders can be managed to ensure that necessary steps are taken to properly prepare the lab, processes, and staff for implementation.
- How does the new system/updated system affect my staff’s competency and training needs?
- New software may affect not only staff training, but also staff functions. Staff training programs can be designed to target new required skills and processes. Your Project Manager should be able to assist with options on how to structure training to fit into lab operations.
- What changes in roles and structure might I want to make/need in my organization?
- Often the initial implementation of a LIMS creates new critical roles and redefines the roles of other laboratory staff. An experienced Project Manager should be able to suggest opportunities for the rising stars in the organization to gain additional experience and take on new responsibilities.
- Once the system is installed, am I done?
- It is unusual when the laboratory is “done” upon software implementation. What other needs or follow-on activities are likely after implementation? Your Project Manager should be able to prepare a roadmap that could include additional features or follow-on capabilities that can be added to the system.
- What other things should I consider?
- How do the LIMS Project Manager’s previous experiences, together with our unique laboratory environment, help to identify other factors to consider? Assess the experience and knowledge of your PM as you gain insights with the answers to this question.
Asking the Right Questions can Improve Your Project
As we have seen, a LIMS implementation or upgrade is a complex effort that needs to be managed to reduce risk and ensure that company objectives are met. The use of a LIMS Project Manager greatly improves the chances of a successful project outcome.
Have you implemented a LIMS? Did you use a LIMS Project Manager rather than a generic or vendor supplied Project Manager? If so, what was your experience? If not, do you wish that you had?