Blog

How to connect already existing AQbD with the new ICH Q14? Jean-François Dierick and Claudia Magagnoli from GSK explained us how!

An efficient control strategy will ensure your processes performs always as expected. In this blog post we described the steps to design one.

This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.

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 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.

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

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.

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.

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.

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.

The new ICH Q14 guideline is here! How to implement it? We talked with Jean-François Dierick and Claudia Magagnoli on how they did it at GSK.

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

Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.