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Transform medical device risk management by digitalizing processes, improving compliance, efficiency, and collaboration while reducing errors and audit challenges.

See how ValGenesis iRisk transforms pharmaceutical development by integrating QbD and AQbD, streamlining processes, improving quality, and expediting approvals.

Learn why using quality risk management (QRM) software is crucial for ICH Q9 R1 compliance in the pharmaceutical industry.

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.