While quality control (QC) laboratories play an important part in a research operation, often there is a disconnect between that vital component and other parts. The lack of effective integration, among other things, can lead to reduced speed, diminished reliability, and other quandaries.
Jason Boyd, senior director of Vault LIMS with Veeva, connected with Outsourcing-Pharma to discuss the problems QC laboratories typically struggle with. Additionally, Boyd (who worked with Merck before entering his current position) shared some aspects of its new Veeva laboratory information management system (LIMS) and how the tech seeks to deal with some common issues.
OSP: Could you please share some of the key challenges that QC laboratories face?
JB: The QC lab is a component of a supply chain, which means that efficiency while achieving the right level of quality is the goal. Right now, there's tension there because data tracking and organization are paramount to success. Since most QC systems grow from paper-based processes and spreadsheets, companies usually add one application at a time.
The principal challenge I've seen most often is QC labs having too much data across siloed systems and processes. These systems usually don't talk to each other, requiring a lot of "swivel chair" activity.
For example, an analyst takes care of a step in their workflow in one system, this step of a workflow in another separate application, and so on. It requires logging in and logging out of multiple applications. Then you have another issue around where data sits and how does it get correlated but since the analyst needs to keep going, this becomes a methodical strategy.
Companies can't afford to shut down for six months, retool, and return to the lab. To enable a new, more connected way of working, you need to rethink how labs have run in the past.
The ability to do process engineering and apply a methodical approach to build a coherent technology roadmap can lead companies to a connected, digital quality platform. This should be the pursuit for most companies in the industry, but it is a hard journey to embark on and requires vision, planning, and precise execution.
OSP: How do those challenges increase/compound when an operation is stretched across several locations in different regions? What kinds of problems can arise when integrating a number of labs?
JB: It doesn't have to be worldwide; it can even be in the same facility. Take chemistry, for example, where you have a lab and a micro lab that might be a floor apart in a facility. They may have drastically different ways of working, not just because their tests are different, but because leadership has made distinctive choices in processes and systems. Each team has the liberty to creatively design the processes to extract the most efficiency from them.
In the end, each team within the same lab can end up working on different systems. This makes connectivity, particularly for a larger-scale organization, very challenging. Lab leaders are designing their own master data and using unique naming procedures. When the data gets merged into a global system, it doesn't all fit together. Continuity is lost in QC because of that, and it makes it hard to streamline lab operations.
OSP: Could you please talk about some of the solutions QC lab leadership typically turn to in order to help deal with some of these challenges?
JB: This usually goes through different paradigms of thought. One of the first, often common ways is that consultancies analyze laboratory operations and tell leaders they have micro-operating companies and data that doesn't fit together. They can help stop this trend and establish a strategy to ensure everybody works the same way.
But usually, this is met with resistance and escalations from internal teams. It is a good approach and worth pursuing, but if teams have had autonomy for too long, companies need to bring things together and help their leaders see the value in the change, which will generate efficiency on its own.
An issue that could derail these efforts is that lab leadership will go out and buy IT products because a non-challenged philosophy exists. Lab teams need to do things faster, so we need new technology to do that.
Often what happens is that an IT system is brought in, sometimes even without involving the IT organization, and existing processes are replicated on the new system. This limits the benefit of the system because they are trying to do things the same way it was done on paper. This 'ready, fire, aim' approach makes it harder to bring together lab operations. Bringing in a digital point application is not the solution for lack of connectivity or low efficiency.
As an industry, we have to find ways to raise the level and improve how everyone operates, and to do so, we need widespread participation. At Veeva, we have this rare opportunity to design a LIMS from virtually a blank slate.
The power of Veeva Vault, being the platform that serves as the foundation, gives us a flexible starting point. We're interacting and engaging with industry leaders and growing biotechs to, for example, get lab analyst cycle times right.
Our vision for Vault LIMS is to work closely with the industry and the lab managers in the trenches every day, to live their challenges and frustrations. This will help us design a LIMS that will make a real difference.
OSP: Please tell us some of the ways that COVID-19 has complicated things for QC labs.
JB: What the pandemic has shown is the dependency on inefficient workflows. COVID provided clear guidance around who needs to be in a physical lab location and who doesn't. The QA employee that turns paperwork and reviews it for quality are not traditionally crucial personnel within the production, so that person likely doesn't have to be in the plant itself or even in the QC lab. Except for if you have a process that moves a manila folder around the lab, you need that person present to turn the page.
With the pandemic, all of a sudden, you have a broken process because that person's not at their desk. Companies are accelerating digital investment to gain flexibility. Document management systems are starting to be more widely utilized instead of strictly paper. That's an example of digitization.
However, that QA person can't get to the audit trail of the instrument because that information is not extracted anywhere right now. That only lived at the instrument. We can establish data standards and drive interoperability even for aspects that aren't required.
COVID has shown us what was needed to continue operations during an uncertain time and what can be in the future. I think it is driving investments in the right areas, and the industry is making positive change by stretching its view of a quality process.
OSP: Could you tell us how QC lab leaders can get a better handle on their operations using Veeva, other tech solutions, or consulting services?
JB: If you look at the typical IT structure within a quality organization, sample management is a natural starting point because when you pull a material or sample from a batch, you need to label it. Simple things like hazard labels or the subsequent tests that need to happen, or even what batches this sample is from need to go on the label.
But then, as you get closer to the bench and away from the manufacturing line, the tests there are more physical. Less managing information, more of tracking physical activity. You have a decreasing amount of digitalization and an increasing amount of paper at this level.
Therefore, data is in unstructured formats and not mobile. There are a lot of controls around this process to make sure you don't lose the document and that data is transcribed accurately.
A better way to get ahold of lab processes is to design a complete workflow that incorporates end-to-end lab execution. Instead of manual processes, the balance used to weigh a sample is seamlessly connected to the LIMS system. Things like serial identifiers, firmware versions, last calibration date are all captured in LIMS. This will streamline execution and minimize manual throughput for QA teams down the road.
The more that we can lift the data captures at the lab, truly digitalizing information and the method that's been executed, it will enable better analytics, portability of data, and greater efficiency across the life cycle.
Veeva is well-positioned to help the industry solve lab challenges and bring QA and QC together because we have a platform to manage data volumes. Our vision for Vault LIMS is about getting closer to the bench, designing interfaces that work seamlessly with laboratory systems like choreography and simple instrument systems.
Vault LIMS product release workflows will be the first thing coming to market with integration to these other lab systems. This will help lab leaders get holistic data from the instruments while also sharing and capturing that information within Veeva's Vault Quality Suite.
We want to enable companies to move beyond the "Which tool do we select?" and more towards "How are you building a connected platform for quality?" We are adding LIMS capability to the existing Vault Quality Suite so that it is easy for a customer to build out their quality platform.
An example of how this will help is if you're operating in a lab and you have an unexpected result, what happens in almost all LIMS systems is it requires a stop. Lab managers have a physical conversation, open a different application, and begin the laboratory investigation workflow.
Veeva's ability to start that workflow in Vault QMS directly from Vault LIMS means that the lab supervisor and the analyst can have a collaborative experience in the same system to complete the process. And probably most importantly, the finishing of the QC activity and the release of that batch is restricted now by the digital QMS process.
As we build up our Vault Quality Suite and add sample management and test execution, the QC workflow to the QA activity, we'll enable better compliance through a complete digital process. This will allow labs to stop relying on manual processes and working through these human gaps between multiple systems.
