CSA—To Formally Test or Informally Test, That Is the Question
The FDA’s Case for Quality initiative seeks to shift the focus from validation as a check-the-box regulatory activity to one that centers around quality. The shift will ensure that patients and end users have access to safe, effective care. Recognizing that innovation drives continuous improvement, which, in turn, leads to higher quality and efficiencies in products and healthcare; the FDA issued the Computer Software Assurance (CSA) draft guidance in September 2022 to make validation of regulated systems less burdensome and more strategic.
