With the proliferation of quality control (QC) digital projects to improve lab efficiency, more QC leaders are adopting standalone applications that narrowly focus on a specific need. This can lead to individual labs using different tools to execute processes, making connectivity and unification difficult, reports Jason Boyd, Senior Director, Vault LIMS, Veeva Systems
Without a holistic quality data and workflow view, these disjointed solutions, coupled with increasingly complex lab workflows, cannot deliver the expected outcomes or planned return on investment (ROI). The opportunity to transform QC labs is driving growth in the LIMS market, which is projected to reach a value of $1.8 billion by 2028.1
Although positive change in QC lab operation is happening, more work remains to address growing system silos and complexity while improving quality and agility.
Quality leaders looking to drive change in QC can implement three strategies that will help them to advance toward an agile, digital and connected lab. Such a policy can streamline sample management, test execution and lab investigation processes for faster batch release and reduced inventory expenses.
Although every organisation is unique, most lab managers are trying to find better ways to streamline their lab throughput. Rather than starting with “this specific tool will solve our challenge,” encourage your organisation’s key technology strategists (think CIO or head of IT) to combine identified business problems with the organisation’s technology pursuits.
Often, QC includes a mix of manual processes that rely on paper, spreadsheets and homegrown solutions or vendor-provided point solutions. Looking at the complete quality ecosystem and evaluating improvement options that modernise multiple business processes can make a significant positive impact on the organisation.
For example, if analysts use various systems to upload and download files throughout several departments, a single document repository for all document collaboration can relieve some of the pain they experience daily when logging in and out and choosing the right system for each document type.
As QC labs need more than one application to bring together their operations, mapping out end-to-end business processes can help leaders to determine what systems or activities need to be streamlined. This process helps to assess what to keep, what to expand and what to decommission. Key considerations include whether the applications currently being used are sustainable, driving cost savings and aligning with the organisation’s roadmap.
Driving successful transformation in terms of quality requires an investment to establish a comprehensive platform. Assemble a team representing the complete quality business process to define an achievable timeline, detail the priority of capabilities and establish a strategy for organisational change management.
Consider consulting firms and vendor services as an extension of this team to ensure that all the capabilities and expertise needed to address any bumps encountered along the journey. Combining internal leaders, industry experts and partners can provide the right mix of people to ensure a successful transformation.
Once you have the right people on board, decide whether building or buying technology makes the most sense. Developing a matrix for technology selection that encompasses current and future needs and new and existing products, services and support can drive the conversation forward.
The goal should be to enable more connection and collaboration throughout quality and manufacturing. When evaluating technology, consider the following:
Modern systems on a single technology platform can make it easier to unify the quality ecosystem, from quality assurance (QA) to training to change control and QC. Completing this transformation streamlines end-to-end processes for more efficient execution.
Having a connected solution for all quality data and documents will end the “we don't know what’s where” conundrum. Because creating and using a spreadsheet is often viewed as the easiest solution to an existing challenge, organisations need to establish a comprehensive business process supported by an intuitive platform. This will stop the swivel chair approach whereby personnel pivot from one screen to another, often logging in to different systems simultaneously.
By bringing a problem into the broader quality ecosystem, establishing a team of key stakeholders and conducting a thorough technology evaluation, lab leaders can drive speed and agility across the manufacturing plant. This can optimise lab management and accelerate batch release, improving operations and delivering more value from QC.