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Computer Software Assurance (CSA) Guidance

The U.S. Food and Drug Administration (FDA) has long encouraged a risk-based approach for software that focuses on assurance, not validation. CSA is a framework identified by the FDA that brings clarity to computer system validation (CSV).

A guidance document from the FDA was released for Computer Software Assurance (CSA) in September 2022. It is intended to provide recommendations to life sciences companies on computer software assurance for computer systems and automated data processing systems that are used as part of medical device production or the quality system.

The FDA is promoting a Case for Quality approach, which allows life sciences companies to focus on improving product quality and patient safety. Two issues that have driven the FDA’s approach are 1) The industry lags in the implementation of automated systems and new technologies due to the lack of clarity, outdated compliance approaches, and perceived regulatory burden, and 2) Companies often struggle to understand the root cause of issues to improve product quality.

The CSA guidance focuses on clarifying risk-based methodologies to justify the amount and types of testing required and encourages leveraging previous testing activities.

Download the white paper to learn more. > > >

Continue your CSA learning:

  • Watch our recent webinar to hear directly from the FDA’s Francisco Vicenty, Program Manager, Case for Quality, and USDM subject matter experts (SMEs) learn about the changes and implications impacting medical devices, pharma, and biotech organizations.
  • Read our frequently updated FAQ to get all your questions answered.
  • Contact USDM with your most pressing questions and concerns to talk directly with our SME or learn about CSA training options for your organization.
  • Explore our CSA services to fast-track your implementation and transformation.
  • Download the official guidance document from the FDA’s website.
  • Download our datasheet for more information on CSA.

White Paper

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