Drug shortages have been a growing worldwide issue in recent years and represent a significant negative impact on patients’ lives. As we saw during COVID-19 and now, with Russia-Ukraine war, pharmaceutical manufacturing and distribution are facing many challenges. However, the risk of unavailability or limited supply of a drug can be Read more…
CSA is an easier and less-resourceful way to validate your computer software. The good news is that if you already use a Digital QRM system you’re one step closer to easily implement CSA. Let’s see! Imagine that you have something to do, your brain is going to rapidly process how Read more…
Recent world events have been showing pharma companies the importance of having an effective business continuity plan (BCP). Risk management is a crucial part of the business continuity plan, but it can be a challenge for the pharma industry, given the complexity of the supply chains. One example that is Read more…
The last few years have been full of advances in the field Advanced Therapy Medicinal Products (ATMPs). And, as any products that interfere in the health and well-being of patients, it requires a Quality Risk Management System. Which brings us to this blog post: why a Digital QRM System for Read more…