Iterating a Validated Assay? You Need Effective Change Management

Laboratories face frequent changes. Whether you’re implementing new workflows or updating an existing one, adding an instrument, iterating on a validated assay, or optimizing processes to keep up with market conditions or advances in technology, one thing is certain — change is inevitable. But that doesn’t make it easy.

Humans naturally resist change. We prefer tasks that are comfortable and familiar. Habitual or routine tasks take less energy to complete but we also enjoy having a sense of mastery over our work. Change, on the other hand, brings discomfort, uncertainty, and even fear. The result: 70% of business change projects fail.

Change management can help labs both manage changes and prepare people for change. However, the quality of your change management processes can have a big impact on your success. In fact, research has found that organizations with excellent change management (compared to poor change management) are six times more likely to meet their objectives. That’s a significant difference in outcomes.

Factors that affect change management

If you want to ensure that your lab has effective change management in place, there are two key areas to consider:

  • Processes and procedures. Do you have clearly-defined change management processes in place? In our last post, we talked about the importance of diagramming processes. A visual representation of your change management processes can help everyone on your team understand how changes will be managed. If you don’t currently have documented change management processes, this is a good first step to building your change management toolset.
  • Culture and communication. Are people in your organization receptive to change? Do you have clear communication around changes? Have you created a briefing package for your internal leadership and managers so they’re prepared to reinforce the change? How you will communicate change should be described within your change management processes. The communication itself needs to be transparent and reassuring, explain why the change is occurring, describe the benefits of the change, and encourage questions. With a shared vision of the future, your staff will be more invested in the success of the project. If you’re wondering how you can instill a culture that embraces change, check out these 14 suggestions from the Forbes Coaches Council.

Changes that need to be managed in the lab

When you define your change management processes, you’ll also want to make a list of the changes in your lab that need to be managed in this way. Each item will have unique change management requirements.

Here are a few to consider:

  • Regulatory submissions.
  • Software integrations.
  • Standard operating procedures (SOPs) and laboratory processes.
  • Human qualification processes, including records of training.
  • Inventory and inventory qualification processes.
  • Software development. (Hint: here’s how a developer might accomplish change management in AWS, for example).
  • Scheduling and timing, and how everything comes together.
  • Your laboratory organization and its response, in general, to the change.

The role of the LIMS in change management

In the lab, the laboratory information management system (LIMS) is impacted by change management in two ways — how changes affect the LIMS itself, and how the LIMS manages change.

First, changes to the LIMS require change management. Common changes include hardware maintenance or upgrades, updates to the operating system, or refinements or new functionality added to the LIMS application. It’s important to note that any time you make changes that could affect data accuracy, security, or integrity, you must revalidate the LIMS. Fortunately, it’s standard practice to use configuration management to control and track changes to the hardware and software, and you can use this to support your validation processes.

In addition to configuration, the LIMS code itself should also be managed with version control. If you track code changes, you’ll be in a better position to resolve issues and manage the risk associated with changes. In the event something goes wrong, you can roll back the code to a previous stable version.

Second, the LIMS performs change management when it tracks sample data during analysis. But potentially, it could also track the changes to a sample as it moves through a workflow — including the technicians involved in processing the sample, the reagents used, and all associated metadata. Tracing data in this way, what’s known as data provenance, is critical in a lab environment for a number of reasons, including auditability, regulatory compliance, patient safety, and, in the case of data reuse, repeatability.

Ideally, your LIMS would support change management of the other sources of change listed above. Instead of someone in your lab managing change manually or using an entirely separate tool, what if your LIMS had enterprise resource planning (ERP) functionality built right in? You’d be able to easily manage changes across the lab from a single convenient software solution.

Our approach to change management

Effective change management is imperative in a lab environment, especially for big changes — such as implementing software systems like a LIMS, building custom applications like order portals, or creating new workflows. The more proactively you can manage change, the better. Making a change in response to an emergency or to meet a firm deadline means additional pressure on staff and can lead to errors that could have been avoided.

Moving a big software change from the development environment to the lab’s production environment also requires careful planning and consideration. You need to obtain approvals from stakeholders throughout the process and perform rigorous user-acceptance testing to ensure that everyone is on board and properly trained before a change is implemented. This itself is a workflow that needs management, in addition to belonging within your change management processes.

We believe your vendor and software systems should support your change management efforts, so we always use a formal change control process that includes sign-off from stakeholders. Beyond that, we have developed a state-of-the-art LIMS to provide labs with even better support. Labbit makes change management easier by improving communication between stakeholders. It also tracks, bundles, and deploys a set of changes as a single unit, and enables accurate data provenance, thus supporting faster laboratory-developed test innovation life cycles.

If you’d like to learn more about how a LIMS could support change management in your lab, get in touch with us today.