Blog

Discover how digital CPV enables real-time quality monitoring in pharma and supports continued process validation across the product lifecycle.

Understand the importance of assurance needs in the FDA’s Computer Software Assurance (CSA) approach and how to implement risk-based validation activities.

Many validation projects go over budget or fall behind schedule. Avoid these 6 common pitfalls to ensure your next project is a success.

A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.

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.

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.

The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.

This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising performance expectations from patients, stakeholders, pressure from government bodies for cost reduction, and regulators necessitate rapid change in execution.