Blog

This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.  

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

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

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

Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.

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.

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.

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.

Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.

A blog post about applying digital transformation to the QRM of the top-tiers of the Pharmaceutical Companies and how it can benefit them.

This is a post about optimising a perfusion cell culture, using a combination of Root Cause Anlysis and Corrective and Preventive Action.

A blog post where we give you some tips on how Quality Risk Management can help you improve your Medical Cannabis business

ATMPs are a field that is new, complex, and specific. Having a digital QRM System for ATMPs can have a strong impact in your operations.

In this blog post we will talk about the perform Risk Management of Sterilising Filtration. We present the steps, the methods and the tools!