Computer System Validation (CSV) in Clinical Trials

Computer System Validation is a premise for Integra IT to ensure that data and solutions are reliable; validating all of our solutions is one of our core activities and our central quality promise.

Since 2002, the FDA has stated the General Principles of Software Validation, guidelines applicable to medical device software validation. The main goal of Integra IT, following the FDA’s guides and other guidelines, is that our software systems withstand rigorous testing and verification.

Our quality processes are focused on three things; impact on patient safety, product quality, and system integrity. We want to give customers confidence that our solutions can be used without limitations since we know data is the most valuable asset. We also understand our customers’ dependence on reliable solutions and higher system performance to achieve their objectives.

Therefore, complete data management is the goal; it requires many activities and validations to avoid inaccuracy and human error. To surpass the challenges of protecting the data is critical to have an effective, proactive, and non-reactive process of validation.


All regulatory entities globally require a validation process to be in place; ignoring this step can result in data corruption, compromise of the software solution integrity, customer risk, a lower level of trust, and regulatory non-compliance.

CSV (Computer Software Validation) 

In the software environment, CSV ensures that the tasks a system is designed for are fulfilled. Additionally, verify control over user operations, data security, and local and international regulations compliance.

The activities for the CSV in Integra IT include

  • Specification of user requirements.
  • Define specifications of the functional requirements.
  • Preparation of the validation plan.
  • Qualification of the operation.
  • Execution of all validation activities.
  • Preparation of the validation report.
  • Maintain system release documentation.
Validating computerized systems is not only a way to avoid losing business profits and mitigate risks, but it can save lives; for example, detecting defects in a drug in a clinical trial can prevent unfortunate side effects and avoid significant damage that a patient would otherwise have received.

In compliance with the requirements of systems validation in the industry, we have developed internal validation procedures and guides for all of our software solutions. This experience has given us an excellent knowledge of the applicable regulations. Nowadays, we comply with:

The validation of our systems has given us many benefits, such as:

  • Legal compliance with FDA/EMA: We can provide all the documentation to regulatory bodies for our validated solutions.
  • Reduce compliance risks: Have evidence that the system works as expected in inspections by regulatory bodies.
  • Detect defects before the start of a system: In this way, we prevent image losses and fraud.
  • Give a method for continuous improvement: Validation allows adding new features to a system.
  • Maximize system efficiency: Validation reduces operational and functional costs.

Relationship between CSV and Quality

Ensuring solutions and applications development with high-quality standards has always been a priority for Integra IT; through the execution of efficient, timely, and excellent quality projects that meet the regulatory requirements of the Validation of Computerized Systems (CSV).


Clinical trials must meet high standards of Quality based on records (electronic and paper), and to ensure this quality; we rely on Computer System Validation (CSV). Complying with CSV and the correct maintenance of the validated status of the software solutions allows us to guarantee that all systems will perform correctly and keep a trusting relationship with our customers.

Do you want to learn more about CSV?


If you want to know more about the considerations for complying with the regulations, you can contact us at

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