Software Validation & Central IT Systems
Expert CSV services for GxP-regulated environments
Software validation remains as critical as ever, from automation and digitization to artificial intelligence and machine learning. QbD Group offers software validation and CSV expertise to help your company comply with the latest regulations.
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 more. It is applicable to key GxP processes and provides control of, and insight into, the computerized systems used in GxP processes.
Why partner with QbD Group?
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.
Process understanding
We help you understand the processes in which your computerized system is used.
White-box approach
We understand the functioning of your computerized system from the inside out.
Lifecycle decision
We help you decide on the lifecycle and software validation approach best suited for your organization.
Data compliance
Ensure highly consistent data and compliance with all relevant regulations — the first step towards data integrity.
Tailored approach
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 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.
Risk-based approach
Tailor the validation effort to the complexity and risk of your system using a risk-based methodology.
Documented evidence
Establish documented evidence that your system consistently meets predefined specifications.
Lifecycle management
Adopt a lifecycle approach from planning and specification through testing, release, and ongoing operation.
GAMP5 methodology
Leverage the industry-standard GAMP5 framework for structured, efficient, and compliant validation.
Why QbD Group
Your trusted partner
QbD Group combines deep life sciences expertise with software validation know-how to help you navigate regulatory complexity:
Extensive experience across various GxP environments and regulatory frameworks.
Tailored validation strategies
from traditional CSV to approaches for AI and ML.
Full lifecycle support
from planning and specification to testing, deployment, and ongoing compliance.
GAMP5 expertise
leveraging the industry-standard framework for structured, efficient validation.
Let's talk Software
From system validation to digital transformation, our software experts are ready to support your journey.