Mahboubeh Lotfinia

The final FDA guidance on Computer Software Assurance (CSA) was released in September 2025. This was followed by an update in Feb 2026 incorporating Quality Management System (QMS) based on ISO 13485:2016. Many proponents particularly outside of the medical device ecosystem have said that CSA will replace Computerised System Validation (CSV). But will it? Really?

A proposed update to United States Pharmacopoeia (USP) <1029> was published in July 2025 for industry comment. What’s changed and are the changes significant?

We critically review the qualification and validation approaches in the World Health Organization Technical Report Series (WHO TRS) 1019 Annex 3 and its applicability to spectrometer systems.

The United States Food and Drug Administration (FDA) is using Remote Interactive Evaluations (RIE) to assess regulatory compliance, review submission material, or determine the timing of future inspections. Here, we look at some of the impacts of RIE on GxP laboratories. Although RIE is voluntary, is this an offer that you cannot refuse?