CSA (vs) CSV: Major steps involved in the Validation Process?

Article Context:

1. Computer System Validation
2. Computer System Assurance
3. CSA (vs) CSV Advantages

For health and life sciences organizations, compliance with regulatory requirements is non-negotiable. Historically, Computer Systems Validation (CSV) has been the focus of QA and compliance activities, but increasingly, organizations are taking a more proactive, agile, and risk-based approach to compliance through Computer System Assurance (CSA).

Although both approaches seek to ensure the reliability, accuracy, and efficiency of computer systems, they differ significantly in their implementation, scope, and overall benefits. Let’s define CSV, CSA and delve into the advantages of CSA over CSV and why organizations should consider adopting CSA as the “go-to” approach for computer systems validation and compliance. It is time for us to rethink our traditional CSV approach.

What is Computer System Validation (CSV)?

Computer System Validation is a structured and in detailed approach to validate a computerized system which performs GxP functionalities. A CSV is a must to render a software valid and accepted by regulatory authorities as a replacement of the manual procedure.

Think of CSV as a linear approach, where every part of the software was held to the same standard, and the focus was testing to a certain rigor without focusing so much on the intended use. As technology advances and picks up speed, these exhaustive CSV efforts are no longer sustainable.

As the CSV approach became a bottle neck for Industry validating a Computerized System and the focus was shifting from producing a quality product to a huge set of documentation just for evidence to auditors, CSA came to existence.

What is Computer System Assurance (CSA)?

CSA is a risk-based, agile approach to computer system compliance that focuses on identifying, assessing, and mitigating risks associated with computer systems. This methodology emphasizes collaboration between stakeholders, streamlined processes, and continuous improvement. Unlike CSV, CSA prioritizes critical thinking, flexibility, and innovation, which better aligns with the dynamic nature of technology and the increasing complexity of computer systems.

Advantages of CSA over CSV:

When comparing CSV vs. CSA, it’s clear how the latter can provide a better overall experience over current processes, making it a high-value solution for life sciences. The major difference is the approach. The following are the advantages of CSA program:

1. Emphasis on Critical Thinking and Collaboration
2. “Thinking-and-analysis first” approach
3. Enhanced Flexibility and Scalability
4. Reduced Documentation Burden
5. Focus on critical testing
6. Encouragement of Continuous Improvement
7. Cost and Time Savings
8. Better Alignment with Regulatory Expectation

Considerations for a good CSA program:

Strong Quality Management System can contribute for an easy implementation of a good CSA program:

1. A strong Supplier Assessment Program.
2. Use a risk-based approach, or your in-house risk management process.
3. A strong internal change control process.
4. Strong internal processes and procedures along with adequately trained and competent personnel will reduce the need for detailed test scripts.
5. Use of Automated Testing Tools. Follow an Agile approach for development and consider unscripted testing as part of the validation approach for low-risk testing.
6. Finally, when defining what is required, ensure you know the intended use of the system.

Conclusion

In a nutshell, CSA is a more critical thinking-driven and efficient approach compared with the CSV approach. As a regulated company, you need to ensure your computer applications meet your needs for functionality, patient safety, product quality, and data integrity. Unneeded documentation, redundant testing, and perceived regulatory burden distract us from our primary goals to protect public health and encourage technological advancement in our manufacturing systems.

Some companies have been apprehensive about adopting CSA because they think of CSA as having “no documentation” – which is a fallacy. The key thing to identify when comparing CSA vs CSV is that with CSA, there is less but better planned and more useful documentation.

For assistance on your move from CSV to CSA, on how do you think critically about risk, how to trust your team and adjust to this new CSA approach, Compliance Group Inc offers CSA implementation services to ensure efficient validation, seamless compliance, and optimal results. Streamline your validation journey with our Industry thought leaders support and stay ahead in the ever-changing regulatory landscape. Stay informed and make informed decisions for successful software validation.

As always, we are ready to help! For more elaborate details on the CSA program implementation, contact us at sales@complianceg.com for more info!