Computer System Validation

Computer system validation, or CSV, remains as critical as ever, from automation and digitization to artificial intelligence and machine learning.

Are you looking for CSV services? QbD offers CSV expertise to help your company comply with the latest regulations. Don’t hesitate to contact us for more information.

Computer System Validation - QbD Group

What is Computer System Validation?

ENSURING CONSISTENT PRODUCTS

Computer System Validation is defined as the establishment of documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets predetermined specifications and quality characteristics.

CSV is a regulatory requirement according to regulations like 21 cfr. Part 11, Annex 11, ICH E6 (R2), and so on. It is applicable to key GxP processes and provides control of, and insight into, the computerized systems used in GxP processes.

Why QbD Group?

EXPERT TEAM WITH YEARS OF EXPERIENCE

QbD has years of experience with numerous projects in various GxP environments.

If required, our validation approach can be tailored to newer technologies, such as machine learning and artificial intelligence.

We are happy to help you: 

  • understand the processes in which your computerized system is used
  • understand the functioning of your computerized system (white-box approach)
  • decide on the lifecycle and Computer System Validation approach

and ensure highly consistent data and compliance with all relevant regulations. The first step towards data integrity!

Computer System Validation - QbD Group (1)

Tailored approach

FLEXIBLE SERVICE

The actual approach and life cycle you want to take to validate your computerized system(s) is up to you.

The most common and recognized CSV approach is the GAMP5 methodology.

Contact us

TALK TO AN EXPERT

Don’t hesitate to contact us so we can listen to your needs and provide you with the right Computer System Validation services.

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