Difference Between CSV and CSA


In September 2022, the U.S. Food and Drug Administration (FDA) released a draft guidance on software validation, introducing a new approach called Computer Software Assurance (CSA) for production and quality system software. This guidance marks a shift from the traditional method of software validation, known as computer system validation (CSV), towards a risk-based approach. The purpose of this article is to explore the differences between CSV and CSA, highlight the benefits of CSA, and discuss how medical technology (MedTech) companies can adapt to this new software validation approach.


1. CSV and its Challenges:

Computer System Validation (CSV) is a form of software validation that relies on extensive testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. While CSV provides objective evidence of software meeting user needs and intended uses, it often results in a significant amount of documentation, time, and effort. MedTech companies, on average, use multiple software tools, making CSV a burdensome and costly process.

2. CSA: A Risk-based Approach to Software Validation:

Computer Software Assurance (CSA) is a risk-based approach to software validation introduced by the FDA. CSA encourages MedTech companies to consider the risks associated with software failures and determine appropriate assurance activities accordingly. Rather than testing all software equally, CSA prioritizes more rigorous assurance activities for high-risk software. This method allows companies to allocate resources effectively and focus on software solutions that pose the highest risk to their operations.

3. Benefits of CSA for MedTech Companies:

The shift from CSV to CSA brings significant benefits to MedTech companies. It reduces the burden of software validation, freeing up resources to focus on high-risk software and intended uses. By adopting CSA, companies can explore new technologies and utilize more Software-as-a-Service (SaaS) tools without the excessive validation requirements. This promotes innovation, compliance with FDA regulations, and the efficient adoption of new software in the MedTech industry.


The FDA's introduction of Computer Software Assurance (CSA) as an alternative to Computer System Validation (CSV) represents a significant shift in software validation approaches for MedTech companies. CSA's risk-based approach allows companies to allocate resources more effectively, prioritize high-risk software, and streamline the validation process.

Read also: Computer System Validation (CSV) in Pharmaceutical Industry

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