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The Importance of Change Management in Validated Systems

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 …

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How You Can Increase Profits by Moving from Planned to Predictive Maintenance

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 …

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Lean Validation: Why It’s Important and How to Achieve It

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 …

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An Introduction to Equipment Systems Engineering

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 …

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What Is Vendor Neutral and Why It’s Important to Your Manufacturing Facility?

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 …

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What is Aggregation in Serialisation and Why Is It Important?

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 …

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The Business Opportunities of Digitalisation and Digital Transformation in Manufacturing

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 …

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7 Industry 4.0 Trends that Will Influence Manufacturing in 2019

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 …

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Security Challenges of Industrial Automation Control Systems

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 …

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QBD, CQA, CPP, PAT – Understanding Process Validation Terminology

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 …

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A New Approach to Delivering Bespoke Software Solutions to the Regulated Sector

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 …

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The Smart – and Cost-Effective – Way to Improve the Performance of Production Lines

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 …

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Video: Validation Services Explained

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

Automation of the Batch Changeover Process – Saving the Time Between Batches You Don’t Have

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 …

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The 3 Stages of Process Validation Explained

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 …

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Industrial Automation Control Systems and How They Improve Businesses

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 …

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Demystifying Industry 4.0

Remaining competitive and profitable requires constant improvements in productivity, customer service, quality, regulatory compliance, and flexibility. Industry 4.0 promises to deliver these improvements. Often, however, there is too much hype and/or misunderstanding surrounding Industry 4.0. It’s time for some clarity. The Industrial Revolutions Let’s start at the beginning: Industry 4.0 is another way of describing …

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OEE and Why It’s Important

OEE is one of the most important performance measurements in modern manufacturing facilities. By optimising OEE, you can increase capacity, reduce costs, improve quality, and/or increase efficiencies in your production lines. Now, here is the really interesting part – it’s possible to achieve significant performance gains in your manufacturing facility by optimising OEE. Before getting …

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Benefits of Automating Regulatory Compliant Data Processes

The way your manufacturing facility processes data is becoming more and more important. This is true of manufacturers in all industries as consumer demands increase and competition becomes more advanced. Data processing is particularly important, however, in heavily regulated industries, such as the pharmaceutical and medical device industries. In these industries, the benefits of automating …

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Falsified Medicines Directive – Potential Challenges You Should be Aware Of

The deadline for the implementation of solutions to meet the new Falsified Medicines Directive (FMD) is fast approaching – the new regulations go live on 9 February 2019. You can find out more about the regulations, including how the new systems will work, on our blog Falsified Medicines Directive – Are You Ready? What about …

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Digitisation and Digitalisation – You Need to Know the Difference

If you run a manufacturing facility, you need to know the difference between digitisation and digitalisation (or digitization and digitalization if you are reading this in the US). The difference is crucial to understanding Industry 4.0, plus it will help you develop strategies to transition your facilities into smart factories. The difference between the two …

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