Validation Planning for Computer System Validation

Validation-Planning

1. Validation Planning Validation planning is crucial for GxP regulated systems. It ensures patient safety, product quality, and data integrity. A well-structured plan is essential for compliance. ValSquare

2. Corporate & Site Level Policies Corporate Policy Roles and responsibilities High-level expectations Standards and templates Process definitions Documentation requirements Site Document Summary of systems in scope Current status Change control process Planning and scheduling

3. Validation Master Plan (VMP) 1 Scope Defines the boundaries of the validation activities. 2 References Links to relevant policies and existing documents. 3 Organization Outlines the structure and responsibilities. 4 Summary Brief overview of systems and processes.

4. Computerized System Validation Plan Patient Safety Ensuring the system protects patient well-being. Product Quality Maintaining high standards in product manufacturing. Data Integrity Guaranteeing accuracy and reliability of data.

5. Key Validation Activities Requirements Identifying system needs. Activities Defining required tasks. Responsibilities Assigning roles. Acceptance Setting compliance standards.

6. Roles and Responsibilities Project Manager Planning, control, and reporting. Quality Unit Ensuring regulatory compliance. System Owner Supporting implementation.

7. Validation Strategy Components Risk Assessment 1 System Assessment 2 Supplier Assessment 3

8. Key Deliverables & Acceptance 1 List Deliverables 2 Deviation Management 3 Acceptance Criteria Define deliverables, manage deviations, and set acceptance criteria.