Q&A: Accelerating Processes

Andrew Smith: Manufacturers are experiencing tough scrutiny across the globe, and the spectrum of their industries, especially in quality control activities, safety reporting, and manufacturing operations. Organisations have, therefore, started paying more attention to reduce risks through the implementation of strong management controls.

Electronic batch records (EBR) were once mainly used for helping pharmaceutical companies automate away the mountains of paperwork required for maintaining production batch records.

When part of the FDA specification known as title 21 of the Code of Federal Regulations part 11 was issued, production facilities were permitted to use EBRs to document each step in the production, packaging, and handling of every batch of their products. Since then, industries began to realise how automating batch records can also help them improve workflows and efficiencies.

Governments around the world are designing and implementing anti-counterfeiting regulations. While the regulations each have their unique flavour, they share similar approaches in requiring manufacturers, not only in pharma, but also other consumer packaged goods sectors, to use serialisation systems for product traceability and authentication.

Complying with these regulations will be critical for global manufacturers operating in multiple countries. With the growing need to reduce errors and overheads, along with effective process control and quality management, EBR technologies are developing rapidly and are set to continue seeing steady demand over the coming years.

Advances in EBR systems represent a new future filled with opportunities for manufacturers that are still reliant on paperbased reporting systems – opportunities to be compliant, more productive and more cost-effective.

Technologies such as advanced analytics of digitised operations enable businesses to accurately forecast how they can scale production to meet market demand, and positions them for datadriven decision-making.

It provides real-time insight into the functioning of their production lines, where they are losing productivity, what steps are creating bottlenecks, where preventative maintenance is required and any process improvements that can be made. To achieve this level of insight, manufacturers must have connected operations, enabling the large volumes of data produced by their connected assets to be contextualised. This allows tools such as analytics to deliver real value.

Meanwhile, artificial intelligence (AI) is helping these businesses make the right decisions faster, as it thrives on complexity, crunching through multi-vector data at a speed impossible for humans. It is also being widely used in the drug discovery stage. Businesses that have adopted technologies, for example, independent cart technology (ICT) has a high degree of flexibility already built into its production lines. These technologies enable businesses to rapidly adapt to changing demands and deliver increased throughput and much faster machine changeover times to produce new products at scale. A high degree of automation means that less on-site intervention is required than with traditional production lines, enabling plants to run effectively on a skeleton staff.

Time-to-market is critical for pharma manufacturers who want to meet customer demands and maximise profits before patent and product expiration dates. There are multiple ways to accelerate time-to-market by using a modern and dynamic EBR.

The quality assurance teams can use its review-by-exception functionality to spot deviations much faster than scanning every record line by line to find them. Not only can it speed up documentation review times and reduce the time required for releasing a product from the warehouse, but it also can improve batch accuracy and consistency.

Pre-validated recipe building blocks available in advanced EBR systems can be reused to achieve shorter deployment times. Instead of time-consuming, custom programming and validation, recipe authors can use a library of instructions to create new workflows in minutes.

Likewise, real-time information access creates opportunities to speed up processes throughout the production cycle. For example, gauge data can be automatically collected vs requiring a worker to physically walk to each gauge and record their readings.

The ability to collect and review process information helps make the identification and removal of unnecessary tasks, such as redundant material checks and weight verifications, easier.

Moreover, the time savings only become greater in a connected enterprise. The ability to connect an EBR system to mobile devices, for example, can give workers faster and more convenient access to information anywhere on the plant floor.

Pharma producers are transforming their operations through digitalisation to drastically improve competitiveness.

Access to more data and simpler control architectures can help improve changeover time and drive production toward operational excellence. Others are using a modern manufacturing execution system to help increase their number of batches processed by more than 50%, or to go fully paperless.

We’ll likely see this trend continue as new regulations, like anti-counterfeiting laws, push even more pharma producers to adopt connected and information-enabled operations. However, digitalisation in pharma cannot be discussed without also addressing industrial security. Already today, many pharma companies fear that greater connectivity will put their intellectual property and other sensitive information at risk; they worry that outsiders will interfere with production in ways that can compromise product quality.

While these concerns are well-founded, they needn’t stop your digitalisation plans. By following established best practices and using industry resources, you can strengthen your industrialsecurity strategy and better protect trade secrets, operations, and products.

Some have used the risks that connected technologies can introduce as an argument against modernisation, but it’s important to recognise that doing nothing is not a solution. Maintaining legacy systems too long not only deprives you of valuable insights and other Internet of Things (IoT) benefits, but these systems also often lack the security measures of contemporary systems making them more vulnerable rather than less.

The better approach is to make the most of digital transformation, while helping protect safety and security as part of the process. As you do this, keep some key things in mind.

For example, many security practices have long been used in the IT world, but they’re new to the IoT world. And, while many of the mitigation steps are similar in comparison, they’re applied very differently in the front office than on the plant floor.

In a manufacturing environment, cybersecurity and safety risks should both be part of risk management and part of the management of change process. Environment, health, and safety, professionals should be involved in managing processes and compliance with standards and laws.

It’s a new age in industry. The advantages of Industry 4.0 certainly outweigh the increased risks. By understanding the risks and mitigating them as part of your digital initiatives you can expand what’s possible in your operations, while helping protect what matters to you most.

While the cloud gets all the glory in the technology curve, the Edge has been relatively underutilised in the analytics story. Considering many important industrial analytics use cases require a hardware control system response time within milliseconds, sending data to the cloud, retrieving the insight back, and then acting, isn’t enough – the network delay and data transmission costs are too high. So, it makes sense to offload data processing and analytics at the Edge, so that appropriate prescriptive action can be taken in real time at the hardware control layer – which can make all the difference. Leaders in analytics are also deploying intelligent Edge gateway solutions – hardware or software – as part of their strategy.