Computer System Validation
(การตรวจสอบระบบคอมพิวเตอร์)
Definition
Computer System Validation (การตรวจสอบระบบคอมพิวเตอร์) Tool
The process of ensuring that a computer system meets its intended purpose and complies with regulatory requirements through planned and documented activities.
Expertise Level
Level 1
Basic
1. Understands the fundamental concepts and purpose of computer system validation.
2. Recognizes key regulatory requirements related to system validation.
3. Assists in basic documentation and record-keeping tasks.
Level 2
Intermediate
1. Can plan and execute validation protocols according to guidelines.
2. Performs risk assessments and mapping of system requirements.
3. Prepares and reviews validation documentation for accuracy and completeness.
Level 3
Advanced
1. Leads the entire computer system validation lifecycle ensuring compliance and quality standards.
2. Develops complex validation strategies and resolves compliance issues.
3. Trains and mentors team members in best practices and regulatory updates.
