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ALCOA+ is a set of principles that ensures data integrity in the life sciences sector. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration. It has relevance in a range of areas, particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain. As well …
What is ALCOA+ and Why Is It Important to Validation and Data Integrity Read More »
The benefits of Industry 4.0 technologies, processes, and systems include improved productivity and efficiency, better flexibility and agility, and increased profitability. Industry 4.0 also improves the customer experience, including through more personalised and intelligent products. Understanding and then contextualising these benefits is important, particularly in highly regulated industries like medical device, pharmaceutical, and biopharmaceutical manufacturing. …
The Project The project outlined in this case study involved integrating the PAS-X MES platform into a customer’s production line. The customer is in the life sciences sector. SL Controls’ parent company, NNIT, was the lead on the project. NNIT provided full support for the integration process, including scoping, design, deployment, and validation. The first …
MES (manufacturing execution system) platforms are becoming increasingly indispensable tools in manufacturing facilities, including in the life sciences sector. There are many MES options available (including PAS-X), so it’s important to get the right advice and support to ensure the implementation of a solution that works for your organisation today and into the future. In …
What Is PAS-X and Is It the Best MES Solution for Your Pharma Manufacturing Facility? Read More »
The regulated sector, including pharmaceutical and medical device manufacturers, is going through a period of transformational change. These changes are being driven by new product innovations, market pressures, the evolving regulatory landscape, and customer/end-user demands. MES solutions, powered by the platform Ignition, are enabling manufacturers to respond, including manufacturers in highly regulated industries. SL Controls …
Microsoft Cloud for Manufacturing is on its way. It was announced last year as one of several new industry clouds that Microsoft is developing, and it is currently in preview mode. What can manufacturers in the pharmaceutical, medical device, and technologies industries expect from this new Microsoft solution? For us at SL Controls, Microsoft’s Azure …
What is Microsoft Cloud for Manufacturing and What Can You Expect? Read More »
There are a number of challenges facing the pharmaceutical and medical device manufacturing industries. Those challenges include labour shortages and developing supply chain resilience. There is also an increasing requirement to become more agile, where production facilities can react faster to changing demands and expectations. Pharmaceutical and medical device companies also have to deal with …
Good Distribution Practice (GDP) is a quality system for warehouses and distribution centres that process medicines. Historically, GDP only covered the movement of finished products from manufacturing sites to wholesalers, retailers, and patients. These parts of the supply chain are still covered by GDP, but the guidelines are now applicable throughout the whole supply chain, …
What is Good Distribution Practice and How Does it Impact Thermal Compliance? Read More »
The past 12+ months has seen supply chains face considerable disruption – disruption that has altered perspectives and priorities. While Covid-19 is not the only reason for these disruptions, it is a significant factor. The pandemic isn’t over yet, either, bringing further uncertainty. While there are uncertainties, there are also opportunities in warehouse and supply …
7 Warehouse Management and Supply Chain Trends for 2022 Read More »
At this time of year, it is common to see articles looking at the trends that will be important over the coming 12 months, particularly in relation to technologies. We even produce these articles ourselves at SL Controls. However, it is also important to look at smart manufacturing and Industry 4.0 more broadly to assess …
5 Crucial Smart Manufacturing and Industry 4.0 Focus Topics for 2022 Read More »
One of the business outcomes that manufacturers want to achieve with Industry 4.0 projects is repeatability. Repeatability is about creating solutions that can be reliably and efficiently deployed multiple times. This goal of repeatability is also important in the delivery of Industry 4.0 and smart manufacturing projects. In project management, this can be referred to …
Project Management: The Importance of Economies of Repetition in Industry 4.0 Projects Read More »
In previous blogs in this series, we looked at one of the unintended consequences of implementing Industry 4.0 technologies and processes – the increased attack surface. In other words, the more equipment you connect, the larger the target for would-be attackers. We also looked at the challenges of dealing with this Industry 4.0 cybersecurity issue, …
An Overview of the Industry 4.0 Cybersecurity Risk Mitigation Process Read More »
In a recent blog, we highlighted the cybersecurity risks that are created by the increasing attack surface in manufacturing organisations. As a quick recap, as you integrate systems, platforms, and equipment, and as you connect elements of your operation to the cloud, the potential attack surface in your organisation expands, exposing you to higher cybersecurity …
Good distribution practice (GDP) and good manufacturing practice (GMP) are quality standards and guidelines that have the same ultimate objective – to ensure medical device and pharmaceutical products are safe, meet their intended use, and comply with regulations. GMP focuses on manufacturing processes, while GDP covers distribution activities. There are crossovers between both manufacturing and …
How Good Distribution Practice (GDP) differs from Good Manufacturing Practice (GMP) Read More »
Businesses in all industries face an ever-increasing range of cybersecurity risks. This includes companies in the manufacturing sector. When you look at regulated industries such as pharmaceutical and medical device manufacturing, where patient safety is a top priority, cybersecurity risk levels can be even higher. Industry 4.0 technologies and solutions almost always modify existing risks …
The Cybersecurity Risks Created by Industry 4.0’s Increased Attack Surface Read More »
For pharmaceutical and medical device manufacturers, repeatability is a primary goal when developing new manufacturing software solutions. The concept is simple – you select a facility or production line for the initial project, creating a software solution to deliver on your manufacturing and business objectives. Once you have that operational and delivering results, you can …
Moving your business closer to becoming a Smart Factory is widely regarded as essential to continuing competitiveness and profitability. Driving efficiency savings, making productivity gains, dealing with skills shortages – these are just some of the challenges that manufacturers face, all of which can be considerably mitigated with Smart Factory solutions. How do you get …
The Essential Steps in Your Smart Factory Evolution Read More »
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 the project …
8 Essential Elements For De-Risking An Automation Project Read More »
Cloud infrastructure solutions, as well as Software as a Service (SaaS), Infrastructure as a Service (IaaS),
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