3 Ways to improve your lab management and accelerate quality control

The importance of the role of lab management and quality management in life sciences cannot be overstated. It’s the backbone of ensuring medicines are produced safely and effectively, directly impacting patient safety. It’s the very core of GMP. However, it’s not without its challenges. The necessary quality control processes involved, can cause unavoidable delays that can ripple through the supply chain.

Before raw materials can be used in production, they must be tested and approved. Finished products also need rigorous testing before they can reach patients. In fact, testing also includes sampling of water and the analysis of bacterial cultures in cleanrooms. It is not solely about the material flow itself but also about the facilities, utilities, and equipment utilized in the process.

While this testing throughput time is usually accounted for in the production planning, unforeseen delays in quality control often affect the production chain. And… the longer the quality control process, the longer it takes to sell the product to customers, resulting in delays across multiple departments – from sales to logistics.

3 bottlenecks in batch release

1.Prioritizing

One of the major bottlenecks in lab management is the complexity and time required for batch releases. Not every batch holds the same priority. A batch with sufficient stock has less urgency compared to a critical product that needs to be delivered to a customer. However, labs do not always have clear insight into these priorities.

2.Pooling of tests

Another challenge is the pooling of tests, where the lab waits to process multiple batches at once to maximize efficiency. This can be beneficial in some cases, but it is always a balancing act. This is especially true when it concerns samples that need to be processed with urgency but are forced to wait due to this practice.

3.Manual lab work

Additionally, the reliance on manual processes and paper-based documentation in many labs slows the entire operations down. Analysis results are often recorded on paper, manually entered into systems, and subsequently reviewed. This not only consumes a lot of time but also increases the risk of human error.

The impact of these inefficiencies on the supply chain is significant. Extended release times create delays in the overall supply chain, leading to higher inventory levels, higher costs, and, in extreme cases, risks associated with product expiration dates. In worst-case scenarios, products are released, only to reach a warehouse with limited remaining shelf life or even nearing their expiration date, creating risks for waste and financial losses, further complication distribution.

There are many challenges regarding the interdependence of your supply chain and your lab management processes, but luckily, there are also a lot of solutions. If – as a manufacturer in Life Sciences – your main objective is to ensure a high product quality, improve patient safety, and do this as efficient as possible by optimizing your lab processes – you have come to the right blog. Here’s how you can achieve this:

Step 1: Simplify your system landscape

A simpler, more integrated system landscape reduces the need for multiple interfaces, lowering the complexity (and costs) of managing different systems. By consolidating multiple solutions for lab management into a single application – preferably one integrated with your ERP (like SAP) – you minimize both initial implementation costs and ongoing system maintenance.

This integration with ERP offers an additional advantage: it allows for better coordination between lab management, production planning and other departments using that application. For example, planning priorities, stock levels, and production demands can all be factored into lab workflows, ensuring that testing and batch releases align with the needs of production, sales, and logistics.

Step 2: Aim for end-to-end data traceability

The more integrated your systems are, the better your end-to-end traceability becomes. When lab and ERP data such as material batches, production data, maintenance data (and more) are all housed in one system, you gain visibility of the entire production process. From raw materials to the finished product. This leads to faster, more informed decision-making and more efficient overall operations.

Step 3: Automate the process

Automating key steps of the batch release process can dramatically improve both speed and accuracy. By moving away from manual entries and paper documentation, labs can save significant time while reducing human error. Direct integration with testing instruments allows results to be instantly recorded and validated without the need for multiple manual touchpoints.

Automation also enables labs to work faster and paperless. When data from various tests is automatically consolidated into a single system, lab personnel can focus on their core responsibilities instead of tedious administrative tasks such as the four-eye principle.

To sum it up: companies that embrace automation and system integration experience faster batch releases, lower operational costs, and reduced errors in quality control processes. For example, businesses using embedded SAP solutions achieve savings not only in labor but also by eliminating implementation costs, and licensing and support fees for standalone LIMS. For lab technicians, digitalization also means being freed from tedious administrative tasks.

Moreover, these integrated systems provide immediate access to critical analyses results. For example, data regarding the concentration of a particular substance in a batch can be instantly shared with production, ensuring that no time is lost between the testing and the next step in the production process. In short: releasing the right batch at the right time allows optimal production planning without standstill.

Steppingstone for fully digitalized labs

Beyond the obvious time- and cost-savings, automating and integrating lab management with production also paves the way for future optimizations. With a unified system, companies can explore other opportunities like digital batch documentation, automated review processes, and more advanced analytics. You can even take that first step to a fully digitalized – and paperless – lab.