How do you define the scope and purpose of CSV vs verification?

The scope of Computer System Validation (CSV) involves outlining the functions and limits of a system, ensuring it meets regulatory requirements. The purpose is to guarantee the reliability, integrity, and performance of the system. Verification in CSV involves testing to confirm that the system complies with defined criteria and specifications.

Below is my point of view Computer System Validation encompasses the entire life cycle of a computerized system, from planning to retirement. It also Ensures compliance, reliability, and fitness for intended use. Involves comprehensive documentation and validation activities at each stage. Whereas Verification targets specific aspects of a system or process to confirm adherence to predefined requirements. It also Confirms that particular elements or features meet specified criteria. It is a focused and specific activity within the broader CSV process. Both CSV and verification are crucial in maintaining quality and compliance of computerized systems in regulated industries, guided by regulatory bodies like the FDA or EMA.

CSV is computer system validation. It is a regulatory requirement and companies required to follow guidelines such as 21 CFR 11, 21 CFR 820, Annex 11 etc.

A clear breakdown of the distinctions between CSV and verification. The post effectively defines CSV's scope, emphasizing regulatory compliance and system reliability, integrity, and performance. Verification, as outlined, is the process of testing to ensure alignment with specified criteria. This concise explanation helps demystify the roles of CSV and verification in ensuring the robustness of computer systems.

CSV (Computer System Validation) is the process of ensuring that a computerized system or software meets regulatory requirements. The scope defines the boundaries of what is covered by validation activities, while the purpose is to confirm that the system performs as intended, meeting quality and compliance standards. Verification ensures that each phase of the system life cycle adheres to specified requirements and validates the accuracy and completeness of the implemented system.

Informative !!! CSV is the process of ensuring that any technology component is fullfilling it's purpose in line with the regulatory guidelines for a certain industry. Woluld like to discuss more about CSA, Please share your thoughts sir.

Verification is a process of determining whether output of one phase of development conforms to its previous phase. It is concerned with phase containment of errors. It involves review, unit testing and integration testing.

Verification is a process to verify systems, software are working as expected. It includes limited testing for the system and software. It is different than Validation.

Verification evaluates software artifacts (such as requirements, design, code, etc.) to ensure they meet the specified requirements and standards. It ensures the software is built according to the needs and design specifications. Validation evaluates software to meet the user's needs and requirements.

Verification Vs Validation !!! Both check that the product meets specific requirements and standards. They also complement each other. For example, performing verification prevents errors in the requirement from making it to the implementation (coding) phase. And validation can further validate that the final product functions correctly.

Verification only verifies the design and few functionality of the system. It includes testing to ensure system can work. CSV follows full validation lifecycle of the system / software as per regulatory requirement. It includes testing to ensure system / software is fit for intended use in a GxP environment.

Both CSV and verification are important for ensuring the quality and reliability of computer systems that support critical processes and products in regulated industries. They help to prevent errors, defects, failures, and deviations that could compromise the safety, efficacy, or integrity of the data or the product.

Verification helps identifying errors and defects. CSV helps in complying regulatory requirement and ensure system / software is fit for intended use in a GxP environment. CSV helps in complying with data integrity and ensure ALCOA principle is followed.

CSV should follow full validation lifecycle of the system / software. Below documentation should be raised or considered: Change Control Assessment (Impact / DI / ERES / Risk) Validation Plan Test documents Test reports Validation Summary Report

I agree. We've mentioned URS here but in my experience the scope and purpose of the system would be defined in a Validation Plan. You'll find that the entire project including installation and the functional requirements are just as important to apply CSV and verification to. It will not be limited to User requirements.