One of the growing trends in the medical device industry is customised products for individual patients. An example is an implant designed specifically for an individual patient. A range of technologies make products like this possible, including new additive manufacturing technologies. Furthermore, customised medical device products offer significant benefits to patients. There are benefits to …
Risks can enter an automation project at just about any stage. Those risks can result in serious consequences from budget and schedule overruns to unplanned downtime, disrupted supply chains, and more. Therefore, it’s important to de-risk your automation project at every possible stage. This ensures errors are reduced to a minimum as well as ensuring …
8 Essential Elements for De-Risking an Automation Project Read More »
Additive manufacturing involves manufacturing a product by fabricating it layer by layer, building it up. It is sometimes referred to as 3D printing, although the technologies involved and the processes that are available are now more advanced than the term 3D printing indicates. All additive manufacturing techniques differ from traditional manufacturing techniques that produce components/products …
Additive Manufacturing in the Medical Device Industry Read More »
As automation, machine learning, sensor technologies, remote monitoring, artificial intelligence, etc advance, manufacturing companies increasingly rely on bespoke software solutions to achieve their objectives. This includes both fully bespoke solutions and software that is customised according to your requirements. Delivering this type of tailored software to the regulated sector – such as to pharmaceutical or …
Delivering Bespoke Software Solutions to Companies in the Regulated Sector Read More »
Cloud infrastructure and Software as a Service (SaaS) solutions offer significant benefits to manufacturers in the pharmaceutical and medical device industries. Cloud-based solutions, including SaaS, still need to be validated, however, just like your in-house IT infrastructure. The main difference, of course, is the introduction of third parties to not only provide a service, but …
Qualification of Cloud Infrastructure and SaaS to Demonstrate Regulatory Compliance Read More »
Batch manufacturing is the tried, tested, and trusted approach for manufacturing pharmaceutical products. There is an increasing push, however, for the industry to switch to continuous manufacturing. A key driver of this push is the FDA – the Food and Drug Administration in the US. The FDA believes continuous manufacturing improves product quality, reduces medicine …
Continuous Manufacturing vs Batch Manufacturing in the Pharmaceutical Industry Read More »
The clock is well as truly ticking on the introduction of the new EU MDR (Medical Device Regulations). The process of implementing this new EU directive started in 2017, with it scheduled to come into force on 26 May 2020, i.e. less than a year from now. EU MDR represents a significant change to regulations …
The UDI and Serialisation Requirements of the New EU MDR Read More »
At SL Controls, we describe the four pillars of successful project delivery as QUAD: Q – Quality U – Utilise A – Accomplish D – Design Quality – The Assurance of a Successful Project Change management Risk management Document control Continuous Utilise – Enabling a Successful Project Resource acquisition Resource retention Resource upskilling Resource …
Infographic – The Four Pillars of Successful Project Delivery Read More »
SL Controls is a company that has deep roots in Sligo. This is where the company was first founded, it’s where we employed our first staff, and it’s the location of our head office. While Sligo remains crucial to our business operations, we now also have other locations around Ireland that are of equal importance. …
Validation is essential in high-volume, highly regulated manufacturing environments such as manufacturers of pharmaceuticals and medical devices. At SL Controls, we provide a full range of Validation Services. Check out our new video to find out more about our capabilities and experience as well as how we work when delivering Validation Services.
Implementing change in a validated system is a crucial time for ensuring it remains controlled. As a result, it is essential that change management is carefully planned and implemented. This is particularly important for compliance reasons, not least because a carefully planned and documented change management process demonstrates to regulators that validated systems remain in …
The Importance of Change Management in Validated Systems Read More »
Unplanned downtime caused by equipment or machine breakdown costs money and eats into your profits. Modern technology provides a solution that offers significant improvements compared to other methods that are used to maintain machines and prevent unplanned downtime. That solution is predictive maintenance. In other words, using real-time data to predict in advance when a …
How You Can Increase Profits by Moving from Planned to Predictive Maintenance Read More »
Validation impacts many critical aspects of your business from productivity to compliance to patient safety to product quality. It’s not enough, however, to have an effective validation process. To remain competitive and prepare your business for the future, you need an optimised validation process. This means lean validation. A lean validation approach delivers everything you …
Lean Validation: Why It’s Important and How to Achieve It Read More »
At SL Controls, we work on projects that involve improving OEE and overall productivity in manufacturing businesses. We do this by integrating platforms, equipment, machines, and systems to streamline the production process, enhance automation, improve the use of data, give greater management oversight, make production lines more efficient, and more. As our clients are primarily …
An Introduction to Equipment Systems Engineering Read More »
In manufacturing environments, vendor neutrality typically refers to software platforms and solutions that can operate regardless of machine or equipment vendors. The aim of this type of software is usually to improve performance as well as deepening levels of integration on the production line to enhance efficiency and productivity. Even for software platforms and solutions …
What Is Vendor Neutral and Why It’s Important to Your Manufacturing Facility? Read More »
One of the most important changes occurring in manufacturing at the moment is the convergence of IT and OT. This needs to be not only on your radar, but part of your current plans for improving your business today and helping you stay competitive in the future. In most manufacturing businesses, there are two types …
The Convergence of IT and OT – Giving You a Competitive Edge Read More »
As a pharmaceutical or medical device manufacturer, serialisation has probably been a key focus for your business for some time now. What about aggregation in serialisation, though? What are the legal requirements? What are the business benefits of aggregation, and will it deliver a return on investment? What is Aggregation? Aggregation can be a part …
What is Aggregation in Serialisation and Why Is It Important? Read More »
Ireland needs more engineers today, with most people predicting this demand will go on long into the future. Therefore, there is a skills shortage that must be overcome and women are likely to be a key part of the solution. Just how bad is the skills shortage problem, though? The Skills Shortage Let’s look first …
Robert O’Hanlon is the Lead Control Systems Field Engineer at SL Controls. Find out what it’s like being a field engineer as well as what it’s like working for SL Controls.
SL Controls is a member of the Atlantic MedTech Cluster, a group that promotes the MedTech industry in the Northwest of Ireland. This video was made by the Cluster to promote SL Controls and what we do.
Digitalisation (digitalization) is a process that results in the digital transformation of a business. It involves moving passed digitisation (digitization) – way beyond digitisation, in fact. With digitALISAtion, you don’t simply move from using paper-based systems to digital systems. Instead, you transform your business, blending the physical world with the digital world so they effectively …
The Business Opportunities of Digitalisation and Digital Transformation in Manufacturing Read More »
Manufacturing technologies are advancing at a faster rate than ever before. In such a fast-paced and busy environment, it can be hard to cut through the information and noise to get to what really matters and what will really make a difference. In other words, the things that will improve your competitiveness in the marketplace …
7 Industry 4.0 Trends that Will Influence Manufacturing in 2019 Read More »
Cybersecurity, system security, and information security are challenges faced by all industries and sectors. For the manufacturing sector, these challenges are particularly acute, especially in relation to industrial automation control systems. The threats to industrial automation control systems are varied: Targeted external attack to deliberately hinder production Targeted external attack to impact the state or …
Security Challenges of Industrial Automation Control Systems Read More »
There are a lot of terms and abbreviations used when discussing process validation, with some more common than others. Understanding these terms and abbreviations is important given the crucial role process validation plays in relation to compliance, product quality, and production line productivity. QBD – Quality by Design In a QBD approach to manufacturing a …
QBD, CQA, CPP, PAT – Understanding Process Validation Terminology Read More »
Like all manufacturers, companies in regulated sectors must innovate and improve their manufacturing processes to remain competitive. Driving efficiencies and increasing productivity levels are ongoing objectives. In addition to this drive to remain competitive, manufacturers in regulated industries must deal with the added burden of compliance. Also, requirements in many heavily regulated industries are changing …
A New Approach to Delivering Bespoke Software Solutions to the Regulated Sector Read More »
Integrating equipment, machines, platforms, and sites to improve productivity is a key objective of most production lines. Automating processes to drive efficiencies is another crucial objective. How can you achieve these objectives with minimal risk and cost, however, while also ensuring full regulatory compliance? The traditional way of automating processes and integrating the elements that …
The Smart – and Cost-Effective – Way to Improve the Performance of Production Lines Read More »
At SL Controls, our validation services include 21 CFR Part 11 compliant software, batch execution systems, source code reviews, process validation, software validation, and equipment validation. Watch our video to find out more. https://www.youtube.com/watch?v=_wkDSrjyBQM
Batch changeovers are an essential part of many manufacturing facilities. They also represent a loss of productivity, however. After all, when you are changing batches, you are not producing products. This is amplified further in pharmaceutical manufacturing facilities where the batch changeover and batch control processes are subject to regulations. So, how do you reduce …
The manufacture of safe and high-quality pharmaceutical products requires good manufacturing processes. This is the goal of Process Validation, i.e. ensuring pharmaceutical products consistently meet quality standards and expectations. The way to achieve this is through the Three Stages of Process Validation. The Three Stages of Process Validation is a protocol published in 2011 by …
Industrial automation control systems are becoming increasingly crucial to manufacturing in a range of sectors. They are often viewed as technical solutions, however, they come under the remit of the senior engineering team at the coalface. The fact is, though, industrial automation control systems impact the wider enterprise, which means they can significantly improve your …
Industrial Automation Control Systems and How They Improve Businesses Read More »
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