55 percent less validation effort – a dream?

Since the Food and Drug Administration (FDA) published the Computer Software Assurance (CSA) Design Guide in 2022, the topic has sparked lively discussions. Opinions on the guideline differ widely.

Critics complain that CSA does not offer any real added value, as the established approach of Computer System Validation (CSV) already covers all essential aspects. In addition, the lack of clarity of the guideline is criticized, which could lead to uncertainties and confusion during implementation.

On the other hand, proponents see clear benefits in adopting the CSA methodology, especially with a focus on risk-based testing. In practice, companies from the medical technology and pharmaceutical industries have already begun to integrate the methodology. This allowed us to gain initial experience and test the practicability and effectiveness of the CSA methodology.

The article explains the central principles and highlights the added value of the CSA methodology. We provide an insight into concrete efficiencies and obstacles that we were able to observe in a customer project.

Current hype: Computer Software Assurance (CSA)

The publication of the guideline on Computer Software Assurance in September made waves in the IT quality sector of the life sciences industry. On LinkedIn in particular, a lot has been posted about CSA and its relevance based on the current publication of the guideline. We want to give you a brief overview of the methodology, explain the usefulness of a real use case and show you a concrete way to use the CSA.

What is behind the CSA methodology?

The CSA methodology was developed by the US Food and Drug Administration (FDA) in response to technological advancements and increasing regulatory pressure. The methodology was published as a draft in 2022 and finally on September 24, 2025. Strictly speaking, the FDA's CSA guideline focuses on use in the medical technology environment, but can also be applied in the pharmaceutical environment. The methodology on CSA presented by the FDA can be considered a subset of computer system validation according to the GAMP®5 guideline. The cornerstone of the methodology is the risk-based approach. The consistent application of the risk-based approach serves to focus on critical software functions, to reduce unnecessary validation efforts and to generally increase efficiency in the validation process.

In simplified terms, the CSA methodology can be summarized in the following basic principles:

• Determination of the intended purpose of the system: Basic classification of whether a system is direct, indirect or not at all part of the production or QA system.
• Risk assessment with regard to functional and process requirements: Assessment of possible consequences for product safety.
• Derivation of appropriate quality assurance measures: Consideration of the intended purpose and the risk assessment in order to derive a test strategy that specifies the depth of testing and documentation against the respective requirements depending on the risk.

What is the added value of the CSA methodology?

Many regulated companies have not yet adopted modern validation approaches due to complexity, lengthy processes or a lack of resources. Adapting the current CSV framework can counteract common pain points such as process complexity and resource scarcity. Especially the time savings in the area of validation of production-related systems can significantly improve production readiness and thus the time-to-market time. In the case of initial delivery or establishment on the US market, the adaptation of the CSA methodology again shows an understanding of the idea of the risk-based approach in authority audit.

55 percent less validation effort: A customer use case

We would like to briefly illustrate the concrete benefits of the method using one of our customer projects as an example. A customer from the global medical technology sector commissioned us to optimise their validation processes. The goal was to streamline the process from requirements gathering to the completion of testing. To this end, we analysed the current CSV framework and revised the central specification documents.

The CSV framework was adapted in close cooperation with the customer and its performance was tested directly in a pilot project. In addition to rapid acceptance by the central application teams, a significant reduction in validation effort was demonstrated. Following the successful initial application of the new framework, the CSA methodology is now used company-wide by our customer.

Before and during company-wide application, typical validation efforts for small (S), medium (M) and large (L) validation projects were monitored. To evaluate the increase in efficiency, the validation efforts were then compared (see Table 1). The validation effort when applying the CSA methodology with inexperienced teams already showed a reduction in effort of approximately 40 per cent compared to the traditional CSV approach. After a year of intensive use, validation effort with CSA-experienced teams was even reduced by up to 55 per cent. The methodology was used independently of the complexity of implementation (commercially purchased, customer-specific development, open source).

What obstacles can arise when implementing the CSA methodology?

The paradigm shift towards risk-based validation must be carefully prepared by creating an appropriate framework. This requires close collaboration between cross-functional teams from quality, IT and business in order to actually achieve efficiencies. The scope of application must also be clearly defined to avoid creating unintended compliance issues. In particular, the associated mindset shift from the current document-centric validation practice to a risk-based approach must be competently supported.

Rethinking validation processes

Regulatory requirements and process approaches to CSV are evolving. CSA is a key lever for greater efficiency: improved compliance with less effort. Modernising processes is more than just changing process diagrams and formally training new procedures. We have had good experiences with targeted organisational change management, especially in large IT projects such as ERP implementations. Our ability to competently plan process changes, test them in small teams close to the user and then monitor their gradual company-wide introduction makes us a strong partner for the efficient use of modern methodologies such as CSA.