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Central IT Systems - Software Solutions & Services - QbD Group

Software Validation & Central IT Systems

Software validation remains as critical as ever, from automation and digitization to artificial intelligence and machine learning. 

Are you looking for software validation services? QbD Group offers software validation and CSV expertise to help your company comply with the latest regulations.

Don’t hesitate to contact us for more information. 

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What is Computer System Validation?

Computer System Validation (CSV) 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. 

Tailored approach

FLEXIBLE SERVICE

 

When it comes to validating your computerized system(s), the actual approach and life cycle you choose to adopt is entirely at your discretion. This means you have the freedom to tailor the process to best fit your specific needs, objectives, and the unique requirements of your organization.

 

This flexibility allows you to design a validation strategy that not only ensures compliance and reliability but also aligns with your operational goals and enhances overall efficiency.

 

The most common and recognized software validation approach is the GAMP5 methodology.

 

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Software Solutions & Services - Software validation - QbD Group

Why partner with QbD Group?

EXPERT TEAM WITH YEARS OF EXPERIENCE 

QbD Group 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 software validation approach.
  • Ensure highly consistent data and compliance with all relevant regulations. The first step towards data integrity! 
Contact us today
Software validation

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Get in touch

Get expert support for your software validation and CSV needs. At QbD Group, we tailor our approach to fit your processes and systems, ensuring compliance with key regulations.


Fill out the form to connect with us, and take the first step toward streamlined validation and regulatory excellence.

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