Computer System Validation Service

Accelerate drug development with InspireXT's risk-based approach to Computer Systems Validation

Computer systems validation ensures that computerized systems used in regulated industries, such as pharmaceuticals, healthcare, and finance, comply with regulatory requirements. It helps organizations meet the standards set by regulatory bodies like the Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Computer systems validation projects face high costs due to a lack of specific implementation guidelines, complicating the determination of the best validation approach. Maintaining compliance during system upgrades is challenging, while improper role distribution and limited cross-functional coordination cause delays and inefficiencies, emphasizing the need for effective teamwork.


InspireXT provides accelerated computer systems validation (CSV) services tailored for life sciences organizations. By employing a risk-based validation approach, we ensure compliance with international regulations, offering a faster and more efficient validation process.

InspireXT follows a comprehensive methodology where infrastructure, installation, and software undergo rigorous testing and qualification ensuring GxP compliance. User acceptance testing is conducted with clients to verify that the validated system meets their specific requirements. These streamlined methods eliminate the need for clients to allocate extra time and resources to validation, enabling them to prioritize research and development efforts.

InspireXT’s CSV consultancy ensures data Integrity and compliance

Our CSV consultancy is led by a team of experienced experts who have vast experience working in the regulated industry. With a risk-based approach at the core, we focus on ensuring data integrity and compliance, providing clients with comprehensive guidance and support throughout the validation process.

Reduce documentation efforts with standardized templates

Streamline your validation processes with our customizable, industry-aligned validation templates for plans, reports, user requirements, validation protocols, and more. Experience significant reduction in documentation efforts while ensuring efficiency and adherence to industry standards.

Ensure compliant validation with InspireXT’s project implementation

Achieve successful CSV implementation by adopting a risk-based approach and industry best practices, ensuring compliance with regulatory guidelines, and maintaining the validated state.

Achieve faster go-live of validated computer systems

Efficiently reduce software implementation time and associated costs for accelerating the validation process of GxP systems. Streamline the configuration, installation, and integration of software components, leading to a more rapid deployment.

Save revalidation time during system upgrades with risk-based prioritization

Measure the impact of each upgrade based on the assessment of its criticality and allowing validation efforts to be focused on high-risk areas and reducing the need for revalidation of the entire system with every upgrade. Ensure that the systems are in a continuous state of validation by adopting a streamline process of managing the updates/upgrades through our concept of cVaaS.

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