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Clinical Trials

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Computer System Validation in Clinical Trials

Validation is one of the good practices required to ensure success in clinical trials

Comply with good clinical trial practice.

Data collection is key in clinical research and one of the crucial phases in the launch of a new drug to the market.

Electronic data collection notebooks are a computerized technological development designed to collect, manage and store clinical and laboratory data.

Since they are computerized systems, their validation is required to provide objective evidence that guarantees that the system is well configured and behaves according to the proposed objectives and security standards.

Main activities

Among others, the following documents are required to be developed:

  • Validation Plan.
  • Own documentation for validation:
    • User requirements.
    • Standard Operating Procedures (SOPs).
    • Protocols, tests, and reports of the IQ, DQ, OQ, and PQ verification phase.
  • Procedures to maintain the validated environment: for change control, incident management, training plan, and user and security management.
  • Procedures for the periodic evaluation of the control status: internal and critical service provider audits.


Computerized data capture through the use of validated electronic data collection notebooks enables pharmacies to have real-time information, more accurate data, accelerate decision-making when there are patient safety alerts, improve efficiency in clinical trial management and reduce costs.

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