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.