Dermot McMorrow

Modern technologies make it possible to create digital simulations, digital twins, and virtual 3D models of products, parts, manufacturing processes, machine processes, systems, and more. Engineers can then use these simulations and models to facilitate the design process, improve quality, identify errors, and improve performance. They can do this by testing multiple design variations in …

Digital Validation and Why It’s Important to Pharmaceutical and MedTech Manufacturers 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 »

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 »

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 …

The 3 Stages of Process Validation Explained Read More »

Serialisation is about securing the supply chain, primarily in the pharmaceutical industry. At a very basic level, it involves applying a serial number and other features to a product, so it can be checked and cross-referenced as it moves through the supply chain to the patient/end user. As you might expect, however, serialisation involves much …

Key Serialisation Terms You Need to Know Read More »

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 …

Falsified Medicines Directive – Potential Challenges You Should be Aware Of Read More »

The deadline for compliance with the new Falsified Medicines Directive (FMD) is fast approaching. If you haven’t already taken steps to upgrade the systems and processes in your manufacturing facility, you should do so now. In most situations, this will involve an enterprise serialisation solution and an upgrade to your packaging lines. Below we answer …

Falsified Medicines Directive – Are You Ready? Read More »

Serialisation in the pharmaceutical industry is one of the best tools society has to combat counterfeit medicines. What are the facts relating to this issue, though, and what do you need to know now about serialisation? Counterfeit medicines are a risk to public health. They are often not effective so don’t benefit patients. If that …

Serialisation in the Pharmaceutical Industry – What You Need to Know Read More »

Serialisation is an important topic in manufacturing, especially in industries like pharmaceutical manufacturing. What is serialisation, though, and why is it important? Serialisation involves adding unique serial numbers to products during the manufacturing process. Those serial numbers must be globally recognised so the product can be tracked and traced and/or identified anywhere in the world. …

What is Serialisation? Read More »

Software projects that result in late budget overruns are never welcome. As a result, most companies take steps to keep tight control on costs, particularly in the early stages of a project. Therefore, the last thing they want to see is a big invoice during the initial scoping and design stages, i.e. before coding even …

How to Justify Early Extra Investment to Reduce Late Budget Overruns Read More »