RQA 2025: Pragmatism Over Perfection: Real-World Inspection Readiness in GCP Bioanalysis

This case study highlights how Arcinova embeds quality through everyday habits and proportionate controls—prioritising real-world readiness over unsustainable “audit perfection”

In July 2023, Arcinova’s GCP bioanalytical laboratories underwent a five-day, unannounced FDA inspection.  The success of this inspection was driven by consistently applied good practices.

Download the poster to see how, with no time for pre-preparation, the team's transparent and 
integrity-driven response demonstrated a strong commitment to regulatory compliance. This mindset of pragmatism over perfection proved key to inspection readiness and demonstrated successful outcomes.