Standard Operating Procedure for Electronic System Validation and Qualification

Purpose

This SOP outlines the procedures for the validation and qualification of electronic systems used in clinical trials and clinical studies. The goal is to ensure that electronic systems function accurately, reliably, and in compliance with regulatory requirements to maintain data integrity and security.

Scope

This SOP applies to all personnel involved in the validation and qualification of electronic systems used in clinical trials and clinical studies, including IT personnel, study teams, and quality assurance staff.

Responsibilities

• IT Personnel: Lead the validation and qualification process for electronic systems, including planning, execution, and documentation.
• Study Teams: Provide input on system requirements and assist in the validation process as needed.
• Quality Assurance Staff: Oversee the validation and qualification process to ensure compliance with regulatory requirements and institutional policies.

Procedure

• Planning and Requirements Gathering:
  • Define system requirements and intended use based on study protocols and regulatory standards.
  • Develop a validation plan outlining the scope, approach, and timeline for validation and qualification activities.
• System Design and Development:
  • Ensure system design meets specified requirements and includes necessary controls for data integrity and security.
  • Document system design and development processes for future reference.
• Validation and Testing:
  • Conduct validation and testing activities according to the validation plan.
  • Test system functionalities, performance, and security measures under various