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Computer System Validation (CSV) to Computer Software Assurance (CSA)

Following the launch of their ‘Case for Quality‘ initiative in 2011, the FDA did not understand why so few companies were investing in automated solutions and why so many continued to run long-outdated versions of software.

The initiative found that the burden of Computer Systems Validation (CSV) deterred technology investments and as a result, inhibited quality best-practice.

As a result, the FDA partnered with industry to strike a balance between promoting automation and value- add CSV activities.

They aimed to improve quality, remove non-value add activities, and focus testing on high risk areas, therefore reducing validation cost and time by focusing on the software’s impact to patient safety, impact to product quality, and impact to quality system integrity (direct or indirect system).

Too often, testers spend time ensuring their protocol is error free, as opposed to spending time on automated solutions that verify the software meets its intended use.

What is the meaning of the shift from Computer System Validation to Computer Software Assurance (CSA)?

Often both business and quality teams are often confused about the what and the why. Fundamentally, the intent of transitioning from CSV to CSA is to change the focus of validation efforts from documenting extensive test suites to executing more extensive system testing to ensure proper functionality.

This shift in approach to validation aims to realign effort to planning and preparation, defining the testing to be performed, and finally test execution and documentation.

There are several fundamentals that CSA ascribes to:

  • Documentation should add value and not be created just to create it.
  • CSA starts with the correct level of requirements defined ahead of time. The appropriate level of lifecycle documentation will be determined by the risk and complexity of the system.
  • The appropriate level of  testing will be based upon ensuring the application functions properly in areas that affect patient safety, product quality and system integrity.

Transitioning to a CSA approach requires a multiphased approach. Included below are some of the highlights:


Assess your company’s current validation landscape.


Create a Transition Plan that outlines the process and timelines for the transition to CSA.


Provide training for the business units and resources.


Once the organization has completed the aforementioned, it is time to implement the CSA framework/methodology, policies, procedures, work instructions, and templates allowing project teams to leverage the new methodology.

Throughout the implementation period, the organization should collect metrics to measure performance against key criteria and business outcomes and adjust accordingly.

Read also: Computer Software Assurance for Production & Quality Assurance

Resource Person: BARBARA PIROLA

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