Governance is a critical part of ensuring systems utilized by organizations are effective and meet the needs of the company, regardless of the type of system. System governance is the oversight of the control and strategic direction of the system, which creates a strong foundation and increases the likelihood of successful system operation.  A Laboratory Information Management System (LIMS) is one example of a system that requires strong governance so that the LIMS is productively utilized and provides optimal support to the company. There are three key elements that must be considered for LIMS governance to have a successful outcome: 

Key Pillars of LIMS Governance

• Establish a Governance Committee or Council: Establishing a leadership group to oversee LIMS governance is one of the first steps to be taken to achieve effective governance. While governance committees may look different between organizations due to their specific needs, some common leadership roles to fill include IT/Business Leadership Representative, Business System Owner (BSO), Technical System Owner (TSO), and Master Data Manager. The governance leadership must set a clear direction for the site or department support teams and system users. Another key responsibility of the leadership team is overseeing communication between the owners of different data management systems at the company, especially if they are interfaced or rely on data from each other, so that system leads are aligned on risks and impacts across the organization’s systems. 
• Roles and Responsibilities: A vital step to LIMS governance is outlining the requirements and expectations of governance leadership and site-supporting roles so that the most fitting candidate can be selected. Clearly define and document the responsibilities of each role and the name of the person accountable – and make that information readily available – so responsibilities are clear amongst the team. Although seemingly straightforward, if not present, the absence of role definition or role assignment can cause confusion, slow progress, and decrease the effectiveness of the team. 
• Continual Evaluation: Continuous improvement is important to avoid complacency, and leadership should ensure this occurs. Regularly review the effectiveness of the system and mitigate any gaps between the system design, business process, and/or organizational needs that may have arisen since implementing the system. Organizations continuously adapt and change based on industry needs, and the LIMS should be regularly evaluated as well. Using a RAID (Risks, Assumptions, Issues, and Dependencies) log to track action items prevents them from being overlooked and gives accountability to the team member responsible for addressing them. Developing a process and recording where improvement requests can be made, evaluated, and prioritized appropriately gives a chance for all involved to be heard. Having these systems in place will enable the governance team to productively act on any findings or opportunities in an organized way.   

Considerations for Companies Utilizing a Global LIMS  

In addition to the three foundational pillars of LIMS governance, there are additional considerations that must be evaluated for companies that have multiple sites and are utilizing a global LIMS.   

• For multi-site companies, there may be additional resource support required to maintain the governance of the larger system. Likely, the role of a site lead for LIMS will be added to represent and serve as the primary point of contact between the global LIMS governance committee and the department leads or subject matter experts (SMEs) at each location. This key member of the site support team plays an essential role as the liaison and provides additional support between the global LIMS team and the site department leads.   
• Depending on the size of the organization and global LIMS system, the responsibilities of core LIMS governance roles, such as a master data manager or TSO, may need to be split between multiple resources due to the demand of the role outweighing the bandwidth of a single resource. In these circumstances, the responsibilities and expectations of each resource in relation to role duties must be clearly outlined and defined. 
• Global LIMS solutions require site security settings and robust training to understand where configuration may overlap. Site security settings keep visible data limited to what is specific to an individual site and prevent errors in reporting. There may be global LIMS objects or configurations that span multiple locations; therefore, detailed and powerful hands-on training ensures that LIMS users are utilizing the system consistently at all sites and in accordance with both the global SOP and any site-specific policies. It also safeguards that master data builds are uniform across sites and that any system changes made by one site do not impact the system for other sites.  
• Locations may have different focuses, such as R&D or Manufacturing, which may lead to slight variances in site operations. Due to these variances in operations, sites may have different needs from the LIMS solutions. Verifying that all system changes are assessed and in accordance with the global LIMS SOP will allow the LIMS to meet the site’s requirements without negatively impacting the system for other locations.        

Ensuring Effective LIMS Governance 

Whether you’re just getting started with a LIMS and establishing governance or in need of a LIMS governance revamp to drive progress, Clarkston can help. With extensive knowledge of LIMS, as well as experience with clients of different sizes and industry focus, we can help develop a roadmap that leads to improving the governance efficacy for your LIMS.