For these reasons, FDA is providing recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality …
Computer Software Assurance for Production and Quality System Software …
Sep 24, 2025 · FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device …
Computer Software Assurance for Production and Quality System Software …
Sep 23, 2025 · Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff
FDA finalizes device production and quality system software guidance
Sep 23, 2025 · The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a …
FDA Computer Software Assurance 2025 Guidance - rookqs.com
On September 24, 2025, the FDA released its long-awaited final guidance on Computer Software Assurance (CSA) for Production and Quality System Software. This guidance introduces a modern, …
FDA’s 2025 Guidance on CSA: What Manufacturers Need to Know
Sep 24, 2025 · At the core of the FDA’s guidance is a risk-based framework for assuring that software used in production and quality systems is fit for its intended use and remains validated throughout its …
In response, the FDA is introducing Computer Software Assurance (CSA)—a modern, risk-based approach that prioritizes critical thinking, efficiency, and quality over burdensome documentation.
FDA Final Guidance on Computer Software Assurance (CSA): What It …
On September 24, 2025, the U.S. Food and Drug Administration (FDA) issued its long-anticipated final guidance on Computer Software Assurance (CSA) for Production and Quality System Software.
FDA: Guidance on Computer Software Assurance (CSA)
On September 24, 2025, the FDA published its long-awaited final guidance “ Computer Software Assurance for Production and Quality System Software ” for medical devices.
FDA Finalizes Guidance on Computer Software Assurance: What …
On September 24, 2025, the FDA released its long-awaited final guidance on Computer Software Assurance (CSA) for Production and Quality System Software, replacing the 2022 draft version. This …