Blog

A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.

Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.

In this blog post we explore the topic of minimising the subjectivity in Risk Assessments through Digitalisation of processes.

Computer software validation (CSV) and computer software assurance (CSA) aren't all that different. So then, what's all the hype about? Let's discuss.

This blog post goes over the key aspects of developing solid comparability studies on early development stages.

Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.

AR-driven hands-free validation isn’t just a futuristic concept; it’s available now. In this insightful Q&A, Steve Thompson discusses how it will transform GMP production environments.

The ICH released a draft version of the new ICH Q14 Guideline last March. This blog post will give you an overview of its key implementation aspects.

ValConnect 2022 is off to a great start! Today's agenda featured live product demos and a keynote from Roche/Genentech. Here's a recap of day one.

Traditional commissioning and qualification can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to adequately track and close out activities.