Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA). It’s founded on critical thinking and intended as an improvement on the long-standing Computer System Validation (CSV) standard. Feeling confused? Don’t be. We’re here to help you through the transition from CSV to CSA the smoothest way possible.

This change has been long awaited. Ever since FDA issued its guidance on General Principles of Software Validation in 2002, the volumes of documentation have been growing out of proportion. “Better to be safe than sorry” has become the common approach in the industry, while the focus on improving medical device quality for patient safety has waned. Now, with CSA, the priorities in the validation process have been reordered. While CSV standard – at least in practice – has been predominantly based on documentation, its successor ascribes key importance to critical thinking.

Common issues with CSV

It’s not like things were poorly thought out from the start. The risk-based approach, now encapsulated in CSA, was promoted by FDA already in 2003 and introduced to CSV by GAMP 5 five years later. With sufficient focus on the system functionalities with the highest risk, CSV serves well enough to achieve compliant computerized systems fit for intended use within a regulated environment in an efficient and effective way.

In reality though, the process is all too often overburdened with documentation which consumes roughly 60% of the time required for completing the validation projects. This doesn’t imply CSV is flawed at its core. The problems usually stem from improper execution and misunderstanding of the validation process. Common issues with CSV application involve the following:

– Insufficient cooperation among business experts

– Insufficient understanding of the intended use of the system subject to testing

– Tendency to maximize testing effort, “just to be sure”

– Demands to provide detailed evidence of testing step by step

– Excessive reviewing of documents

Much of the above boils down to insufficient application of critical thinking in the validation process. With CSA, things are about to change. By no means does it make the CSV obsolete. The new paradigm is rather restructuring than recreating the validation methodology, so that it can help achieve the desired objectives in a more rational and efficient way.

CSA vs CSV – new hierarchy of priorities

The critical thinking underlying CSA model switches the focus from zealous effort to document every action to:

– impartial fact analysis

– pattern identification

– trend assessment

– evaluating outcomes

Combined with a risk-based approach, critical thinking serves to aim the validation effort at the features of the system that are critical to patient safety, product quality, and data integrity. Thus, the central questions the validation team should be able to answer with perfect clarity are:

– Does this software impact patient safety? 

– Does this software impact product quality? 

– Does this software impact system integrity?

CSA – critical thinking for better risk assessment

Combining critical thinking with proper risk assessment allows to address the assurance needs in a proportionate manner. Consequently, the issues requiring more attention won’t be neglected in favor of those of lesser importance, as often is the case with poorly performed CSV. As opposed to its predecessor, CSA results in higher confidence in system performance, rather than excessive documentary records covering even low-risk features where little action is required.

CSA provides not only more reasonable but, in a way, more holistic approach. While CSV focuses on individual steps in a system, the new model aims at understanding the overall business process, in order to better assess the risks involved and apply adequate testing. Therefore, successful CSA completion is highly dependent on seamless collaboration between the experts – skilled professionals knowledgeable about the business processes subject to analysis and testing.

While the “human factor” is crucial, CSA also relies on more extensive use of new technologies, especially automated test tools and systems for digital management of test documentation.

Smooth transition from CSV to CSA paradigm with ecvalidation experts

Essentially, CSA is not about retiring “outdated” CSV standard. It’s about unlocking the potential of a critical mind and collaborative teamwork, as well as overcoming the anxiety related to the responsibility of risk management. As ecvalidation, we’ve completed hundreds of validation projects and have been perfectly aware of potential shortcomings of CSV model.

However, in our individual approach we have always adhered to FDA recommendations regarding the role of risk analysis in validation. Hence, we gladly welcome the transition to CSA paradigm, and perceive it as a valuable upgrade on the previous model. As a result, we’ll be happy to provide assistance to any company interested in smooth implementation of new standards in the validation process.