Blog

Digital validation and automation meet complex product lifecycle needs but they're only enablers to the intelligence at the heart of manufacturing activity. Learn how ValGenesis is expanding its product vision beyond validation toward a holistic manufacturing intelligence platform.

Changing mindsets from compliance-centric to quality-focused isn’t easy. It’s possibly the most difficult change to make, but it’s necessary for a quality culture to take hold.

Each of the above is important. However, the critical point is that data integrity should be designed into the system right from the beginning. Data integrity should be at the forefront of system development (i.e, design).

Cloud-based digital validation allows you to recover in the event of a disaster, ensuring business continuity and compliance.

An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by the FDA. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier.

In this blog post, we’ll go through some concepts on Knowledge Management and the starting points for its implementation.

Unlock the potential of IoT in validation and manufacturing to enhance efficiency, reduce costs, and improve product quality across pharmaceutical operations.

A light story about how ValGenesis joining on a quest to optimize a stage in a process, how did we do it and what came out of it.

This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product

In this blog post, we will give you all the steps about how to create a PACM protocol and how ICH Q12 supports you in it.

In this blog post, we'll give you some tips that help you setting up a Digital CPV plan in only three steps.

In this blog post, we show you how digital validation can improve your validation process and enhance your business efficiency.

The EU has released its GMP Annex 1 revision after 14 years of development! This blog post gives a few ideas on how to apply it more easily.

Learn how Process Analytical Technology (PAT) enhances continuous manufacturing in pharma, improving process control, product quality, and operational efficiency.

In this blog post, we talk about how can you implement Risk Management Processes for Cell and Gene Therapies to every aspect of your product.