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Factors to Consider When Choosing Your LIMS Project Manager
IT projects are notorious for high failure rates. Cloud portfolio management provider Innotas recently conducted a survey in which half of the businesses responding reported an IT project failure within the previous 12 months. Due to a wide range of factors, a successful laboratory information management system (LIMS) project can be particularly difficult to achieve. Some of these factors include:
- A wide variety of complex workflows, processes, instrumentation and technologies utilized in modern labs
- Many modern enterprises have labs in multiple sites
- Some labs perform contracted testing for other companies
- Complex compliance requirements in regulated industries
- Terminology is not standardized across laboratories or industries
- LIMS typically engage a wide variety of stakeholders across the enterprise
- A frequent lack of strategic planning that effectively customizes the implementation to your business
An experienced project manager (PM) who has the ability to navigate all of these factors is critical to the success of a LIMS implementation, upgrade or enhancement project. A good PM will work to organize, motivate and control resources to help ensure that your project
- is delivered on time and within budget
- meets or exceeds all user requirements
- provides business value
- achieves a high-level of user adoption
Unfortunately, we see many LIMS projects that fail to achieve all (and sometimes any) of these metrics. A common theme across these failed implementations is that a qualified project manager was not chosen to lead the project. Let’s explore some of the factors that should be considered when choosing the right PM to ensure success for your LIMS project.
What to Look for in a LIMS Project Manager
While the LIMS vendor may have their own project manager to manage their personnel, you will also need to hire a dedicated project manager that will oversee the entire LIMS project and all the associated personnel from your enterprise, the vendor and any third-party consultants involved. Finding the right LIMS project manager requires identifying an individual with the right mix of technical know-how and soft skills who will be involved in both the planning stages and ongoing management of the project. Important characteristics to look for in a LIMS project manager include:
LIMS Project Management Experience. Your PM should have extensive LIMS project management experience over the full LIMS project lifecycle (project planning to validation and change management) and a proven track record of success. He/she will utilize this experience to offer best practice suggestions and structure your project realistically with maximum chances for success.
Domain Knowledge and Expertise. Experience in your specific industry and laboratory type (QA/QC, Clinical, R&D, Contract, Analytical, etc.), along with some knowledge of the LIMS solution being implemented, is a must for your LIMS project manager.
Regulatory Knowledge. If you are operating in a regulated industry, it is important for your PM to have knowledge of the relevant regulations (e.g., FDA, 21 CFR Part 11, HIPAA, GxP, etc.), along with an understanding of applicable validation requirements.
Communication Skills. A LIMS project will involve stakeholders from many different parts of the organization (IT, QA/QC, bench-level analysts, management, etc.). These stakeholders will often speak “different languages” and may have trouble communicating with each other effectively. It is important to have a project manager who is well-versed in all the different stakeholder domains to facilitate good communication and help avoid misunderstandings.
Ability to Accurately Assess Risk. A LIMS project manager with good system, laboratory and industry knowledge/experience will be able to identify many project risks due to past experience. He/she will be able to provide valuable insights and conduct an effective Project Risk Assessment along with the planning team that provides documentation for:
- Risk identification
- Risk Matrix that ranks these risks in terms of their probability of occurring and consequences
- Risk mitigation strategies
A good PM should be able to mitigate risks by ensuring the right team members have the tools, knowledge and information they need.
People Management Skills. As LIMS projects involve many different stakeholders, a good LIMS project manager should be adept at handling conflict and helping people resolve differences.
Sourcing Your LIMS Project Manager
In order to ensure the success of your LIMS project, it is critical to identify a LIMS project manager with the above-mentioned qualifications. A common mistake is to utilize a generic PM with lots of project management experience but little relevant domain knowledge. Given the complexity involved in a typical LIMS implementation, upgrade or enhancement, such a choice will put your project at serious risk of failure.
If you have someone in your organization with the requisite knowledge, skills and experience, then utilizing them as your LIMS project manager may be the ideal solution. Unfortunately, it is rare for an organization to have a qualified internal PM on staff. Software vendors often have project managers that can do great work in implementing the software, but they should also be able to work with your organization in the project planning phases in order to maximize business value of the implemented system for your organization.
Another option is to hire a qualified LIMS project manager from a respected third-party laboratory informatics consultant. A good informatics consultant can provide PMs that meet all the qualifications described above and will utilize their extensive experience with LIMS implementations (oftentimes with the specific system that you are implementing) to deliver significant value to your organization over the full lifecycle of the project.
LIMS implementations, upgrades and enhancements can be a complex undertaking that needs to be managed to reduce risk and ensure success. The use of a qualified LIMS project manager significantly improves the chances of a successful outcome for the project by driving constraints (on time, on scope, on quality and on budget), ensuring value realization and helping to avoid common people-based challenges.
Astrix Technology Group has over 20 years of experience facilitating success in LIMS implementation projects. Our experienced professionals help implement innovative informatics solutions that allow organizations to turn data into knowledge, increase organizational efficiency, improve quality and facilitate regulatory compliance.
Astrix can provide project managers for your LIMS project that meet all the qualifications described above and have extensive laboratory and industry experience, along with system expertise. If you would like to discuss your LIMS project or explore how to optimize your laboratory informatics strategy, please contact us for a free, no obligations consultation.
About the Author
Edwin Pagoao is a Senior Project Manager in the Professional Services Division of Astrix Technology Group where he is focused on delivering program and project management consultancy services to leading life science and pharmaceutical companies. Mr. Pagoao brings to the role over 20 years experience as a laboratory informatics consultant with a proven track record of driving successful laboratory informatics integrations to improve operations. He has worked with numerous fortune 500 companies during his career to drive continuous IT infrastructure improvements utilizing systems analysis, documentation and implementation.