Advice from Otsuka Pharmaceutical: How CSA is changing the game for Agile teams in health and life sciences
We face risk constantly – even choosing what to eat for breakfast carries risk. Do you choose eggs/meat, which suits keto diets, but can drive toward potential cholesterol increase?
In reviewing your test validation, there’s vastly more risk as software systems continue to increase in complexity in scale. Ensuring 100% validation coverage is a nigh-impossible task, but choosing which systems to prioritize validation scrutiny can be challenging, too. That’s where the concept of Computer Systems Assurance (CSA) comes in!
Watch this webinar to learn how Otsuka Pharmaceutical took this FDA-recommended strategy in refining their validation strategy, as well as:
- How CSA can drive team-wide transformation in validation coverage and confidence
- Where Otsuka began their journey with CSA and their steps along the way
- How to shift away from document-centric validation and towards risk-based validation