Nubilaria's computer system validation service is dedicated to the clinical market.
The EMA Guidelines and the IT Infrastructures

The EMA guideline on computerised systems and electronic data in clinical trials has highlighted the importance of adhering to the minimum requirements mentioned in the guideline, including electronic medical records, as part of hospitals’ IT infrastructure. However, several actors involved in clinical research need to gain awareness of the available tools.

The Validation as a Service (VaaS) ensures that all electronic systems, including electronic medical records, adhere to the minimum requirements cited in the guideline.

The Nubilaria Service for Computer System Validation

At Nubilaria, we validate the importance and urgency of this issue. We have created a specific offer for the system validation service and urge all actors involved in clinical research to utilise validated software systems, also known as Computer System Validation, to ensure that all electronic systems comply with the EMA guidelines.

Our Validation as a Service offer

Basic Validation Package

  • Feasibility / Kick Off
  • GAP Analysis
  • Remediation Plan
  • Validation Training
  • System Training
  • Audit Training
  • Regular Consulting / Check-In Meetings


  • Pre-Validation
  • Kick Off / Feasibility
  • GAP Analysis
  • Remediation Plan
  • System Validation
  • Incl VP, RA
  • Annual Review (e.g. next two years)
  • System Training
  • Audit Support

Customised Package

  • Feasibility / Kick Off

Personalised offer to be discussed.

Emergency Packages

  • Audit Support
  • Maintenance of the validation process
  • Examination of Existing Validation
  • Package / GAP Analysis

The Key Points of our Computer System Validation Offer:

  • The validation tests include a comprehensive range of tests and provide timely and thorough evidence to support the validation process.
  • The documentation should be detailed and exhaustive, providing a complete record for auditors to review.
  • The agile-oriented process focuses on flexibility, adaptability, and continuous improvement, emphasizing collaboration and quick response to change.

Contact US

It is time to take action and ensure that all electronic systems comply with the EMA guidelines. You can contact us for any additional information.