Blog

Learn about ValGenesis iRisk, an advanced tool for digital quality risk management, and its impact on vaccine development at a top biopharma company.

Discover how to leverage digital CPV to apply the ICH Q9 (R1) data-driven approaches and enable bias-free risk assessment in pharmaceutical manufacturing.

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.

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.

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.

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

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.