CSV to CSA: A New Transition in Computer System Approaches

If you’ve ever worked on a computer system validation project, you are probably acquainted with the new FDA’s Draft Guidance https://www.fda.gov/ on CSA ie., Computer Software Assurance.

There was an ambiguity raised by FDA once stated-

“Due to the complexity of software, a seemingly small local change may have a significant global system impact. When any change (even a small change) is made to the software, the validation status of the software needs to be re-established.”

As you can see the previous guidance expresses its ambiguity, which looks like FDA’s requirements for Validation almost not clear and unconfident.

Since then, FDA has identified this ambiguity and come out to substitute CSV to CSA for Manufacturing, operations, and Quality system software which stressed more on “Critical Thinking” that should be part while implementation of Automated systems which is in FDA’s list for release in September 2020.

To support the use of new technologies, FDA is drafting new guidelines “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” hoping CSA will tackle the issues that we have at this moment.

In addition, FDA also intends focusing on Direct Impact systems and not on the Indirect Systems.

In short, FDA clearly understood the importance of critical thinking assurance practices for industries. Now FDA is driving a clear shift from CSV to CSA.  

Now we will see the differences between Computer Software Validation and Computer Software Assurance-

Differences b/w CSV & CSA

Computer Software Validation (CSV)	Computer Software Assurance (CSA)
Regulations on use of Electronic Records and Electronic Signatures were framed in 1997 in 21CFR Part 11 and a revised version released in 2003 and for Eudralex, EU GMP regulations it is Annexure 11 (EME 1998).	Regulations on Non-product Quality systems released in September 2020.
Definition of CSV-Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”.	Definition of CSA- It is a paradigm shift from document focused computer system validation to critical thinking assurance practices.
FDA’s CSV majorly focusses on documentation, testing, assurance needs, and critical thinking.	New CSA model, focusses primarily on critical thinking and then on assurance needs, testing, and documentation.
In CSV, Validate “everything” with the risk to miss higher risk functionality.	Risk-Based assurance approach is the core concept by applying the right level of risk to product quality or/and patient safety.
Spends more time on documentation for the auditor than testing which creates a notable compliance burden.	Spends more time on testing than documentation.
Ignoring previous assurance activity or related risk controls.	Here, accountability is given to prior assurance activities and downstream/upstream risk controls.
The scope of detection of software faults is less as it concentrates more on documentation than testing.	The scope of detection of software faults is more as it concentrates more on testing activities than documentation. Applies to non-product quality systems.
It might miss the higher risk functionality as it lacks conducting more testing activities.	By having a targeted risk-based approach, it improves product quality, patient safety and data integrity.

The US FDA originally aimed at Case for Quality initiative taken in the year 2011 at improving quality of medical devices and for patient safety https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality

Bottom line

The US FDA is providing new guidance that all the manufacturing industries and healthcare organizations should immediately embrace and understand the importance of CSA. This current transition from automated testing to risk-based critical thinking approach will eventually help us to bring patient safety and also improves product quality.

Anticipating this new regulation, as foresight, Avanteva has already constructed A New CSA Approach for future needs.

Ask for a free demo by emailing here- https://avanteva.org/contact/