Digitalisation and smart manufacturing projects and initiatives can come under a number of different headings. One of the most common is paper-to-glass, where legacy, paper-based processes are digitalised and, where possible, automated.

Paper-to-glass projects deliver significant improvements measured against a range of KPIs. They can also help establish a foundation for further digital transformation projects and modernisation initiatives.

This digital transformation case study outlines how the SL Controls team transitioned essential compliance processes in a life sciences facility from paper to glass. The new digitalised, automated, and semi-automated SOPs (standard operating procedures) transformed operations, eliminated errors, and delivered substantial efficiency savings.

The Project

The client in this case study is a multinational medical device company. We were brought into one of its facilities to digitalise and automate processes to drive efficiencies and improve productivity, compliance, oversight, data-based decision-making, OEE, operational agility, data integrity, and competitiveness.

Our client operates a batch production process on an automated filling and packaging line at the facility that is the subject of this case study. The production element of the line was efficient as filling and packaging processes were automated and largely digitalised.

This was not the case with compliance processes. While there was an element of digital record-keeping, essential compliance and quality workflows and SOPs were paper-based and manual. This included:

• Line clearance
• Changeover verification
• Cleaning execution
• Regular maintenance execution

These paper-based and manual processes meant the manufacturing facility could not operate at its full potential. Daily challenges included:

• Human error – staff were required to manually record data on paper before transferring it to a range of different systems, most of which were not connected or integrated. This exposed the company to the risk of human error and the knock-on impacts on batch release timescales, quality control processes, compliance, and data integrity.
• Data integrity issues – data integrity wasn’t just impacted by human error, as even accurate data could be recorded in different formats. There was also a lack of standardisation in the organisation’s systems.
• Inefficient use of resources – the paper-based processes in use by the organisation meant resources were not used efficiently. Operations teams had to spend time on non-value-adding tasks, such as manually recording data on paper and then entering that data into digital systems. Human errors and data integrity issues led to batches being put on hold, resulting in resources having to spend additional time conducting investigations.
• Lack of oversight – the paper-based and digital data that was available could not be relied on to be complete, up-to-date, and correct, reducing oversight.
• Batch release delays – the overall impact of the company’s paper-based, manual systems resulted in unnecessary batch release delays. This had inevitable consequences for the overall performance, profitability, and competitiveness of the facility.

The last point in the list above is worth expanding on further, as batch release delays did not just occur when problems such as human error arose. To a greater or lesser degree, every batch release process took longer than necessary because of the lack of automation and the use of paper-based systems.

What We Did

The solution we developed for the client utilised the Ignition platform, with its modern and highly customisable SCADA and related features. Ignition also has excellent integration capabilities making it ideal for this project as we were working with existing equipment.

Using Ignition, we automated the legacy SOPs for all quality, cleaning, and maintenance procedures that are part of the batch workflow. This included leveraging the available equipment data on the line to automatically confirm equipment status and readiness. These digitised workflows are executed on mobile tablets running the developed application.

The Results

Accelerated Batch Release

Batch release on the production line was accelerated by an average of one hour per shift through a reduction of non-value-adding tasks, a reduction in human error, and the removal of data integrity risks.

Risk Reduction

The new system removed paper-based risks of completeness and quality control.

21 CFR Part 11 Compliance

The new solution fully complies with 21 CFR Part 11, and the system is fully validated.

Quicker Decision-Making

Operators, supervisors, and managers have access to real-time data, improving oversight, speeding up decision-making, and enabling data-based decision-making.

Improved OEE

Digitalising 20+ processes accelerated batch release and raised the bar for equipment OEE (overall equipment effectiveness).

Scalability

We implemented the Ignition platform so it could be efficiently and effectively expanded across other systems, processes, equipment, and production lines both within the facility and in other facilities operated by the client.

John Downey, Portfolio Operations Manager at SL Controls, said: “The part of this project that is the focus of this case study concentrates on batch release and related compliance and operational processes on a filling and packaging line in a regulated facility. However, it also clearly demonstrates the power of not only the Ignition platform but also the concept of transitioning legacy processes from paper to glass.

“Our client has advanced technologies in a number of areas, particularly production processes. Compliance and quality processes had fallen behind in the digitalisation push, so remained paper-based, manual, resource-intensive, and prone to error.

“The transition from paper to glass was smooth using the Ignition platform and the solution our engineers developed. Ignition is more widely used across the facility, but the benefits of this specific part of the project were significant, immediate, and measurable.”

Don Pearson, Chief Strategy Officer at Ignition by Inductive Automation, said: “We have worked with the SL Controls team on a number of Ignition implementations over recent months and years, and we are delighted they are one of our Premier Integrator partners.

“There are multiple applications for the Ignition platform in the life sciences sector, including in the essential areas of quality control and regulatory compliance. Digitalising these processes through Ignition is possible even when using legacy equipment, and this project shows the results that can be achieved.

“We are proud this medical device facility now uses Ignition for a range of operational and compliance purposes, and we look forward to further expansion of the Ignition platform in the future. Well done to the SL Controls team for another successful Ignition implementation.”

Digital transformation is a key priority for manufacturers in the life sciences sector. A crucial element of most digital transformation strategies is the implementation of MES (manufacturing execution systems) and/or modern SCADA solutions to digitalise processes and increase automation.

The customer who is the subject of this case study wanted to achieve this objective. They are a large multinational corporation in the life sciences sector with a manufacturing facility in Ireland. The MES platform we were tasked with implementing was POMSnet Aquila MES.

The Project

POMSnet was selected by the customer at a corporate level. To implement the platform, the Irish facility needed a local integration partner.

We were already familiar with POMSnet at SL Controls, and we could see synergies between the platform and the skills of our engineers. In addition, we have a close and long-standing relationship with the customer, plus our engineers are very familiar with the technologies in use at its Irish manufacturing facility. These factors put us in an ideal position to deliver this project.

What We Did

As with many projects of this nature, the implementation of the POMSnet platform would take place in phases. The first phase involved digitalising two manufacturing processes.

Project Requirements

Our team started by gathering the project requirements, reviewing the paperwork that was being produced manually, and spending time with process owners and other key stakeholders.

Our approach with digital transformation projects like this one is to get a full understanding of the existing workflows and processes. The people closest to those workflows and processes have the most knowledge and experience, so their contribution to the project is vital to success.

User Involvement

Involving process owners and other key stakeholders at the outset of the project is also important to overcome the natural resistance to change that can exist in any organisation. By involving team members in the project from the very beginning, they feel involved, consulted, and informed. They also made valuable contributions that enhanced the final solution.

The implementation stage also progressed more smoothly because of the involvement of team members at the earliest stages of the project. A primary reason for this is that less upskilling was required at the implementation point as team members were already familiar with the solution and had experience using it during the development stages.

Also, because of the way POMSnet works, the SL Controls team was able to digitally replicate the manual system, maximising familiarity levels for those operators transitioning to new processes and ways of working. The fact that POMSnet is very visual in the way it works also helped.

Solution Strategy & Development

Our initial groundwork enabled us to develop a strategy to digitise the existing manual processes using the POMSnet framework. We developed a master batch record within POMSnet to facilitate the implementation of this strategy. Up until then, the master batch record was paper based.

Following our analysis of the paper-based manual system, we broke the processes down into component parts. We then identified the parts that could be fully automated and presented them to the customer.

The customer selected the elements to automate, leaving us with automated components and components where an operator would have ongoing involvement. Within these parameters, we developed and implemented the POMSnet MES solution, although there were some challenges to overcome along the way.

Collating the Required Documentation

One of the challenges going from a paper-based manual system to a digitalised system in manufacturing environments is collating all the required information and records. This documentation is necessary so our engineers can identify areas of alignment where commonalities exist.

The documentation collation process is difficult because of the various systems, processes, teams, and people involved, but it is important as it reduces development time and improves support. Our engineers worked methodically with the various departments within the customer’s organisation to gather the required documentation.

Legacy Systems

The project involved integrating the POMSnet platform with pre-existing equipment. Completing a project like this on a greenfield site is more straightforward as decisions can be made on equipment that ensures compatibility. In an existing facility, as was the case with this project, we didn’t have that luxury.

Instead, we had to leverage the information that was available without making any equipment or code changes. For example, we couldn’t request changes that would standardise a date format or provide us with additional data. We had to work with what we had.

This is one of the strengths of the POMSnet platform, though. The flexibility built into POMSnet meant our engineers were able to develop workarounds for every integration challenge and limitation.

The Results

The implementation of the POMSnet system went smoothly for three main reasons:

• Involvement of the customer’s team throughout the development lifecycle, from senior staff to factory operators.
• The skills and capabilities of our engineers.
• The flexibility of POMSnet and its extensive range of features

As part of the transition to live, we implemented a hyper-care scenario where support was available to the customer’s team on a rapid response, 24/7 basis. There were minimal calls to our support staff during that period, further demonstrating the success of the implementation.

Some of the benefits that have been achieved with the POMSnet MES platform now up and running include:

• Batch release processes on the two manufacturing lines are now 50 percent faster.
• Batch release processes are now automated on a release-by-exception basis, driving additional efficiency savings.
• Quality and material tracking lookups are now instantaneous as all the data is managed on the POMSnet

The success of the first phase of this POMSnet implementation, and the benefits it delivered, led to the second phase getting a green light from the customer. We are working on this second phase at the time of writing. The successful digitalisation of manufacturing processes also led to new projects at some of the customer’s other manufacturing facilities.

Eamonn McManus, Director of Technologies at SL Controls, said: “Digital transformation projects like this involve utilising some of the best technologies currently available. POMSnet is a great example. But the secret to success isn’t the technologies – it’s people.

“In this project, that included the customer’s team who worked with us through every stage. It also included the POMSnet team who provided fantastic support and, of course, our engineers and project managers who led the project throughout, from strategy creation to solution development to implementation and post-implementation support.

“We are delighted this project was a success and we look forward to helping other customers with their POMSnet MES implementations.”

William Shih is VP of the Professional Services Group at POMS Corporation. He welcomed the successful completion of this project.

William said: “The entire project ran smoothly from start to finish, from the upskilling of the SL Controls team through all development stages through to the successful implementation. As the makers of POMSnet Aquila MES, we know the power of the platform, so it is fantastic to see it delivering real-world benefits on a high-speed, high-volume production line in the life sciences sector.”

Manufacturing execution systems (MES) are becoming increasingly important as organisations strive to improve productivity, compliance, and control while taking advantage of the opportunities presented by digital transformation technologies. The question is increasingly becoming which MES platform to choose, as there is a variety of options available. One of those options is POMSnet Aquila MES (also known as POMSnet).

At SL Controls, we have experience implementing and integrating the POMSnet platform for companies in the life sciences sector. In this blog, we are going to explore why POMSnet should be considered for your organisation and facility.

What is POMSnet?

POMSnet is an MES platform owned by the Constellation Software Company. In various forms, it has been delivering MES functionality to manufacturing organisations since 1988.

Why Choose POMSnet?

We have identified the 11 main reasons why POMSnet should be on your list of platforms for consideration when choosing an MES platform:

• Well-established solution
• Out-of-the-box flexibility
• Comprehensive range of features
• Highly configurable
• Easy to learn
• Integration capabilities
• Web-based
• Hosting options
• Cost-effective
• Reliable support
• Facilitates paper-to-glass initiatives

We can look at each of these points in more detail.

POMSnet is Well-Established

According to POMS, the platform is used in over 200 validated sites, it is used in some of the world’s largest pharmaceutical companies, the user base continues to grow, and it is one of the most widely used MES solutions in the life sciences sector.

POMSnet Offers Out-the-Box Flexibility

Many MES solutions operate on a customisation model where the basic building blocks are provided by the vendor and then you work with an integration partner to customise the platform according to your requirements. POMSnet works differently, as it is both very comprehensive and highly configurable.

What this means is that POMSnet can be adapted to almost any life sciences manufacturing requirement without the need for potentially expensive and complex customisation.

POMSnet Comes with a Comprehensive Range of Features and Modules

As mentioned in the previous point, the out-of-the-box functionality that POMSnet offers covers all MES requirements. Those modules and features include:

• Electronic batch records
• Review by exception and release by exception
• Order management
• Equipment management
• Specification management
• Weigh and dispense for a range of material weighing requirements
• Quality management
• Personnel management
• Worksheets and log books

POMSnet is Highly Configurable

Each of the above feature categories and modules can be configured according to your requirements, ensuring you get an MES solution that is workable and delivers tangible benefits.

POMSnet is Easy to Learn

One of the biggest barriers to digital transformation strategies or the implementation of any new software platform is user buy-in. It is one of the points we address at SL Controls from the beginning of any project, and we continue to work on it throughout. Part of this task is made easier when the software platform is easy to learn and use, and POMSnet ticks both of those boxes.

POMSnet Has Advanced Integration Capabilities

The development team behind the POMSnet platform recognise one of the most powerful benefits of any MES solution is the ability to integrate with other systems in the organisation, especially enterprise-level systems. As a result, POMSnet has been developed to be integration-ready. It comes with tools out-of-the-box that enable integration across your manufacturing software stack, including with ERP, LIMS, and QMS systems.

POMSnet is Web-Based

As POMSnet is web-based, it can be accessed from anywhere and on multiple devices, including phones. The POMSnet solution is also touchscreen enabled.

You Have Multiple Hosting Options

You can host POMSnet on your cloud infrastructure or utilise the POMS SaaS MES Cloud option for comprehensive application and infrastructure delivery and support.

POMSnet is Cost-Effective

Any MES platform you choose should deliver a return on investment and then continue delivering financial benefits in areas like increased productivity, more streamlined compliance, and reduced risks. The pricing model and underlying costs of POMSnet make it a cost-effective MES solution.

You Can Expect Reliable Support

POMSnet is built using common and well-supported technologies that make supporting your implementation of POMSnet easier and more reliable, especially if you work with an experienced integration partner like SL Controls.

POMSnet Facilitates Paper-to-Glass Initiatives

One of the big trends in life sciences is the transition from paper to glass, where current manual processes (that are often paper based) are digitalised and, where possible, automated. POMSnet facilitates your paper-to-glass transition and enables a phased approach with a focus on user buy-in, compliance, process optimisation, and long-term success.

Is POMSnet Right for You?

Do the above advantages and features of the POMSnet solution mean it is the best MES option for your facility or organisation? That will depend on your current infrastructure, requirements, and future plans, but POMSnet is likely to be a contender.

The best approach is to work with an integration partner like SL Controls as we have experience across multiple MES platforms. We can analyse your requirements and match them with the best solution for your needs. Get in touch today to arrange a consultation.

Do you have a legacy SCADA system in your manufacturing facility that is creaking at the seams? Are you worried about the risks posed by your outdated SCADA system, or are you frustrated by the limitations it places on your modernisation efforts? Are you simply fed up with the high and difficult-to-control costs? Upgrading your legacy SCADA system to the Ignition platform is the solution.

SL Controls is a certified Ignition integrator, and we have extensive experience migrating manufacturing operations, especially those in the life sciences sector. From our experience, here are the seven main reasons for starting the process of upgrading your legacy SCADA system to the powerful, modern, and highly flexible Ignition platform.

You Can Reduce and Simplify License Fees

The licensing fees for many SCADA platforms are high and extremely complex to manage and control. It is easy for fees to become exorbitant to the point where the potential increase in fees can put the brake on production line modernisation, upgrade, and improvement projects.

In many situations, it is possible to reduce your licensing costs with Ignition. This is because Ignition is based on an unlimited license model. The unlimited license model means you don’t incur additional costs when you add another client or production line. When you buy an Ignition server license, everything is covered, regardless of how many clients or tags you add. This not only reduces your costs but also makes it significantly more straightforward to manage.

Your Operations Will Be More Secure

Many legacy SCADA systems have minimal or outdated security technologies. This can expose your production lines and wider business operations to substantial cybersecurity risks, especially as you work to increase connectivity, automation, and your use of data.

Ignition is built with security as a core priority, so it features the latest technologies. It is also continuously updated, enhancing security and covering-off new and emerging threats.

Your Legacy SCADA is No Longer Supported

Your current SCADA system could have reached its end-of-life (EOL) and is no longer supported, or the available support might be patchy or non-existent for another reason. You can even have internal support issues, with expert operators nearing retirement age.

EOL and unsupported SCADA systems expose your manufacturing operations to additional risks. They also limit your ability to modernise.

Ignition is a growing platform that is continuously being improved. It has a strong support offering, experienced and committed integrators (including us at SL Controls), and an active community. Whatever support you need, it is available on the Ignition platform.

You Can Do More Than SCADA With Ignition

Ignition is a highly flexible platform with a robust development environment that allows our team of experts to create any type of industrial application.

This includes, for example, eliminating the need to have a SCADA system and a separate MES. Ignition can do it all in one platform. Ignition can also be used as a paper-to-glass solution where you can digitalise existing manual or paper-based processes and incorporate them into the SCADA system as part of the upgrade.

Download our whitepaper on flattening your manufacturing software stack to find out more.

You Can’t Integrate New Technology with Your Legacy SCADA System

It is often difficult or even impossible to fully integrate new technologies with legacy SCADA systems. There can also be compatibility issues when you need to install new production equipment. These integration and compatibility problems can again limit your ability to modernise, impacting performance and giving your competitors an edge.

The Ignition platform eliminates integration and compatibility issues.

Ignition is Highly Adaptable

One of the reasons that companies delay the introduction of new technologies like Ignition is the skills of operators. Existing staff might be very familiar with your legacy SCADA system. They might also be comfortable with it too, so are resistant to change.

Ignition is highly adaptable, however, so the transition to the new platform can be made as seamless as possible. Our team at SL Controls can even match the look and feel of Ignition screens to your legacy SCADA system, increasing familiarity for operators.

Improve Performance, Compliance, Oversight, and Control

Ignition will unleash the power of data in your manufacturing operations while making it easy to control, monitor, and analyse processes. You can also continuously optimise key performance metrics, including OEE, as well as improving compliance processes with automated auditing of every action and interaction.

Migrating to Ignition

The benefits we have highlighted above mean you can expect a rapid return on investment when you upgrade your existing SCADA system to the Ignition platform. In closing, it is also important to highlight that migrating to Ignition is not a one-size-fits-all process.

At SL Controls, we will customise your Ignition platform migration according to your requirements, capabilities, existing technologies, budget, skills, and desired outcomes. Get in touch with us today to find out more.

In regulated industries, CAPA (Corrective and Preventative Action) is a core component of your Quality Management System (QMS). Your CAPA quality process is essential for regulatory compliance reasons, but CAPA is also about improving product safety, operational safety in your plant, productivity, OEE, cost-base, and more – the list goes on.

CAPA aims to identify and stop problems and non-conformities from reoccurring (or occurring in the first place) to ensure continuous quality improvement.

While CAPA is important, the reality in many regulated manufacturing organisations is that it is also time-consuming, inefficient, and unnecessarily costly. Results from CAPA quality processes are often sub-optimal, and even with the best efforts and intentions, your organisation can remain exposed to compliance, commercial, and reputational risks.

Furthermore, most of the time and resources expended on CAPA are focused on the “C” element – corrective actions. This can be because of resource availability as well as a lack of complete or accurate data to work through the preventative component.

In the real world, CAPA is more like EBCAAOPAWDIAAWHETTCAPA – “event-based corrective actions and occasionally preventative actions when data is available and we have enough time to conduct a proper analysis”.

That’s a bit of a mouthful so we’ll stick to CAPA but in doing so, we’ll answer two fundamental questions:

• Why are CAPA quality processes inefficient?
• How can CAPA quality processes be improved?

Why Are CAPA Quality Processes Inefficient?

All manufacturing facilities are unique, with different challenges, processes, and systems. As a result, there is no single answer to the question of CAPA quality process inefficiency. That said, one of the major contributory factors is paper-based processes.

Paper-based processes are in themselves inefficient, and they are prone to human error. Paper-based processes also make it more difficult to quickly identify the problems and non-conformities that CAPA quality processes aim to correct. Predicting potential problems and non-conformities before they occur so preventative actions can be taken is even more difficult.

Even when problems or non-conformities are identified, paper-based processes make the next crucial stage of CAPA costly and time-consuming – investigating the non-conformity to understand the impact, level of risk, and root cause. Accurate and complete paper records may not exist and even when they do, it is often challenging to efficiently locate and analyse them.

So, paper-based systems in regulated manufacturing facilities are a major cause of inefficiency in CAPA quality processes.

How Can CAPA Quality Processes Be Improved?

Digital transformation is the solution, where paper-based systems and processes are digitalised. That doesn’t just mean digitising the storing of records, but digitalising complete processes so the collection, communication, and analysis of records are all automated and digitalised.

Digitalising CAPA quality processes is part of this solution, but the bigger and more impactful element is to progress digital transformation initiatives in your facility. An example is to implement a modern MES/SCADA solution that could digitalise at least 50 percent of current paper-based processes within six months and deliver rapid returns on investment.

Read our whitepaper on how modern solutions make it possible to implement a single system combining both MES and SCADA functionality, reducing costs, installation complexity, and ongoing usability.

By implementing a paper-to-glass solution, problems and non-conformities can be identified and investigated quicker, leading to the faster implementation of corrective actions.

You can also then move more into prediction-based CAPA, where potential problems are identified and corrected before they occur.

Digital Transformation Beyond Quality Control

Of course, the benefits of modern MES-SCADA solutions and digital transformation initiatives go beyond making CAPA quality processes more efficient. Given the crucial role that CAPA has in terms of your QMS and overall operational performance, the impact of digital transformation on quality control and continuous improvement should not be underestimated. In many situations, it justifies the investment even before you consider increased automation, greater availability of real-time data, and improved productivity.

So, the summary is digital transformation will drive significant efficiency savings in your CAPA quality processes.

Download the Whitepaper

Full Stack OT Platforms

Why platforms like Ignition MES and Ignition SCADA are needed and selection best practices

Download the infographic as a PDF

Combined SCADA and MES – Full Stack OT Platforms Explained

Full Stack OT (operational technology) Platforms combine SCADA and MES (manufacturing execution system) functionality into one solution. Here’s an overview:

What is SCADA?

• Data acquisition
• Data communication
• Data presentation
• Machine control

What is MES?

• Production order management, scheduling, and resource allocation
• Document control, track & trace, and quality management
• Production data collection, processing, and analysis
• Maintenance and inventory management
• Reporting and data visualisation

Full Stack OT Plaforms – Combine MES / SCADA Solutions

• Bridge the gap between IT and OT
• Eliminate functionality overlaps
• Enhance audit trail compliance
• Optimise production analytics
• Simplify complex processes
• Retain SCADA functionality
• Support modern protocols
• Increase cloud integration
• Enable full connectivity
• Improve OEE
• Reduce costs

Solution Example

Ignition SCADA with MES functionality – to learn more, download our free whitepaper: Full Stack OT Platforms – Why they are needed and selection criteria best practices

The traditional manufacturing software stack – often referred to as the ISA-95 model – is well established in a range of industries and sectors, including the pharmaceutical and medical device manufacturing industries. Companies have built structures and processes around this model that facilitate profitable production, regulatory compliance, and effective quality control.

However, hierarchical structures like the ISA-95 manufacturing stack are becoming less and less common in the modern and increasingly digitalised world. What does this mean for manufacturers in the life sciences sector?

Flattening the Stack

In the latest whitepaper published on our website, my colleague and SL Controls Chief Technology Officer Paul Clarke puts forward compelling arguments to move away from the traditional hierarchical structure to a flatter software stack. You can read the whitepaper here.

Paul’s conclusions are based on the operational requirements of manufacturers in the life sciences sector today and in the future, as well as the modern Full Stack OT (operational technology) Platforms that are now available.

A good example of a Full Stack OT Platform is Ignition by Inductive Automation. The Ignition platform offers both SCADA and MES functionality and, crucially, there is no compromise. In other words, you don’t need to compromise on SCADA functionality to achieve MES capabilities and vice versa.

The Benefits of Combined SCADA and MES Solutions

At SL Controls, we have a lot of experience implementing Full Stack OT Platforms like Ignition in life sciences sector operations, and we have experience of the benefits this type of solution brings. Those benefits include:

• Solving connectivity issues between systems and equipment at the plant and enterprise level with those on the factory floor.
• Achieving support for increasingly common protocols, including MQTT (Message Queuing Telemetry Transport).
• Streamlined and more efficient regulatory compliance, especially in relation to audit trails and document control.
• Simplified and flexible cloud integration and the associated benefits that cloud integrations bring.
• Enhanced manufacturing analytics with digestible and actionable dashboards.
• Reduced process complexity.
• Improved OEE (overall equipment effectiveness).
• Reduced costs, including operational, training, licensing, and hardware costs.

The Next Steps

Whether you are looking for a new SCADA solution or want to enhance your operations by improving the integration between IT systems and OT systems (known as bridging the IT/OT gap), it is beneficial to consider a combined platform – a Full Stack OT Platform.

In the whitepaper mentioned earlier, Paul says the first step in the process is to define what is required. This includes clarifying what you want to achieve with the project today and in the future. Getting a full understanding of your current infrastructure is also important, both the systems and hardware that make up your IT infrastructure and the equipment and systems that come under the OT heading.

As part of the above process, it is essential to identify the legacy systems that need to be retained and integrated into the new platform.

The above is all in addition to assessing the resources and budget you have available, as well as the consultancy, planning, engineering, validation, and compliance support you will need from an experienced and certified integrator like SL Controls.

To find out more and to discuss the advantages that Full Stack OT Platforms can bring to your pharmaceutical or medical device manufacturing operations, get in touch with us at SL Controls. Or you can email me directly on [email protected].

Manufacturers in the life sciences sector have been going through a period of continual change as organisations automate processes, integrate equipment, and make better use of data along Industry 4.0 principles. Part of this process of change is the growing trend to switch to Full Stack OT Platforms.

Full Stack OT (operational technology) Platforms are single-platform solutions that offer the functionality and features of both SCADA and MES systems. By implementing a Full Stack OT Platform, you will simplify your software stack while improving oversight, control, and productivity. Levels of integration will improve vertically through the organisation, from factory floor to ERP systems, and horizontally across your supply chain.

Modernising the Traditional ISA-95 Software Stack

The ISA-95 manufacturing software stack can trace its origins back to the 1990s. It has evolved over time, with the current versions typically having five levels:

• Level 0 – Component Level
• Level 1 – Field Level
• Level 2 – Operation and Control Level (or the Supervisory Control Level)
• Level 3 – Plant Level
• Level 4 – Enterprise Level

Advances in technologies mean there is now considerable functionality crossover between the best SCADA and MES systems. Modern platforms also offer additional benefits, including enhanced integration and better use of data.

Paul Clarke, CTO at SL Controls, said:

“Modern platforms also make it possible to unleash the true power of data in your organisation through data historian technologies, advanced analytics, and reporting capabilities, and by enabling automated decision-making.”

The Full Stack OT Platforms that Paul is referring to make it possible to flatten the traditional ISA-95 stack and move away from its hierarchical structure. In its place comes more of an eco-system solution that is better able to bridge the gap between IT and OT.

Choosing the Right Full Stack OT Platform

SL Controls has real-world experience of implementing Full Stack OT Platforms in life sciences sector manufacturing organisations. We have used that experience to develop and refine a selection process that ensures you get a solution that fully meets your requirements and delivers tangible results.

We have produced a whitepaper, authored by our CTO Paul Clarke, that makes the case for flattening the ISA-95 stack and switching from separated systems to Full Stack OT Platforms. Paul outlines the benefits of this approach for manufacturers in the pharmaceutical and medical device industries, before explaining the steps required to ensure the right platform is selected.

With our experience and expertise, we can assist with your technology and change management project, from planning and consulting to implementation and operation.

Download our whitepaper “Full Stack OT Platforms – Why They Are Needed and Selection Criteria Best Practices”.

Bridging the gap between IT and OT is a key objective for a growing number of organisations in the life sciences sector. The benefits of doing so are substantial, including having increased OT oversight and being able to use OT data to transform business operations. When bridging the IT/OT gap, it is essential to understand the cybersecurity risks that are involved and how to mitigate them.

Cyberattacks on any organisation can have significant financial and reputational ramifications. In the life sciences sector, there are additional risk factors that are arguably even more important, including the risk to patient safety.

Therefore, prioritising and investing in cybersecurity is essential for life sciences sector organisations.

Competing Priorities

By taking steps to bridge the IT/OT gap, cybersecurity risks increase. In simple terms, IT security is mature and well-established. It isn’t perfect, but IT security is substantially more advanced than OT security.

Potential cybersecurity outcomes include production line shutdowns or compromised product batches. Bridging the IT/OT gap can also expose IT systems to OT cybersecurity vulnerabilities.

OT Cybersecurity Vulnerabilities

There are many reasons why bridging the IT/OT gap can increase cybersecurity risks, but most come under the heading of existing OT vulnerabilities, starting with the vulnerabilities created by legacy systems.

Legacy Systems

Legacy systems are common in many life sciences manufacturing facilities, and they are often central to operations. They also often run on outdated and potentially vulnerable software. Historically this has been tolerated, as uptime was considered more important than fixing something (by updating the software) that isn’t, from an operational perspective, broken.

Connecting these legacy systems changes the equation.

Cybersecurity becomes an essential consideration when connecting equipment to the internet that has never been connected before and, in some cases, was never intended to be connected when it was first developed and manufactured. These legacy OT systems typically don’t have built-in security features and where they do exist, they are often minimal and outdated.

Organisational Culture

The biggest cybersecurity challenges that organisations face are typically not related to equipment or machines. The biggest challenges relate to people, as people are often the softest entry point for a cyber-attack.

This applies when bridging the gap between IT and OT. You have the same people-related security issues that apply to any connected system, but you also have the added complication of disconnected teams. This common lack of coordination and collaboration between IT and OT teams increases cybersecurity risks.

Multiple Systems

OT typically comprises a mix of old and new technologies, equipment, and platforms all with different security features and vulnerabilities. The simple fact of having multiple systems increases cybersecurity risks.

There are then additional risk factors, such as OEMs being connected to their equipment for performance monitoring and maintenance reasons. While these types of connections bring benefits, they also create additional entry points for cyber-attacks.

All Production Lines Are Prototypes

No two production lines are the same, even if they are manufacturing the same product. As a result, all production lines in the life sciences sector are essentially prototypes with bespoke integrations and connections. This reality adds to the cybersecurity challenge.

Growth of the IIOT in Health Care

The industrial Internet of Things (IIOT) is transforming many aspects of healthcare with devices that monitor patients and control the administration of treatments automatically and in real-time.

All that new patient data increases the potential value of life sciences sector companies in the eyes of hackers and cybercriminals.

Existing Cybersecurity Solutions

It’s also important to consider existing cybersecurity solutions, as most are aimed at IT rather than OT environments. They are feature-packed, highly robust, and powerful, but they have an IT rather than OT focus.

This can present challenges in OT environments that exacerbate the cybersecurity problem.

Take multi-factor authentication (MFA) as an example. MFA is used in many organisations to beef up cybersecurity and ensure accounts, platforms, and systems are less vulnerable to weak, shared, or hacked passwords.

In a typical office environment, MFA is a small hurdle for users to overcome. They simply use their phone to get the access code from a text message or app to authenticate their login. How can you replicate this in the hygiene-controlled environments of pharmaceutical manufacturing facilities, medical device cleanrooms, or pharma laboratories?

An Introduction to Mitigating Cybersecurity Risks When Bridging the IT/OT Gap

We will explore in more detail in a future blog the mitigation steps that can be taken to reduce cybersecurity risks when bridging the IT/OT gap. The main points include:

• Flatten the stack – reduce the number of systems, particularly in the OT stack, to reduce the potential attack surface for cyber criminals.
• Technical steps – examples of technical steps that can be taken to enhance cybersecurity when bridging the IT/OT gap include creating secure access protocols at every endpoint, encrypting network traffic, and protecting both IT and OT with firewalls.
• Organisational management and people – ensure IT and OT teams work together, particularly on cybersecurity issues, while taking a holistic approach to security that includes both IT and OT teams. Continuously training staff on cybersecurity issues is also important.
• Vendor management – OEMs and software vendors are critical cybersecurity components, so they should be thoroughly vetted and managed.

The most important factor to mitigate risks when bridging the IT/OT gap is to put cybersecurity at the centre of your planning, with cybersecurity considerations factored into every decision and strategy implementation step.