Computer System Validation
Pre-Validation Planning
- Outline the specific goals of validation.
- Determine the boundaries and limitations of the validation effort.
- Identify the systems or components to be validated.
- Establish key performance indicators for success.
- List all individuals and groups involved in the validation process.
- Clarify the roles of each stakeholder.
- Ensure all team members have relevant expertise.
- Engage stakeholders early for input and commitment.
- Create a detailed plan outlining validation activities.
- Set milestones and deadlines for each phase.
- Allocate resources and assign tasks to team members.
- Ensure the plan is realistic and achievable.
- Review applicable regulations that govern validation.
- Identify industry standards relevant to the system.
- Ensure compliance with quality management systems.
- Document all regulatory requirements clearly.
- Identify potential risks associated with the system.
- Evaluate the impact and likelihood of each risk.
- Determine mitigation strategies for high-risk areas.
- Document the findings and recommendations.
- Define communication methods and frequency.
- Specify who will receive updates and reports.
- Ensure clarity on escalation processes for issues.
- Include feedback mechanisms for stakeholder input.
- Assign specific tasks to team members.
- Clarify decision-making authority for each role.
- Document roles in the validation plan.
- Ensure accountability for each validation task.
- List all necessary documents for the validation process.
- Create or source templates for consistency.
- Ensure documents meet regulatory requirements.
- Establish a version control system for documentation.
- Identify training needs based on roles.
- Schedule training sessions and materials.
- Ensure training covers regulatory and procedural standards.
- Evaluate training effectiveness post-completion.
- Specify data handling procedures during validation.
- Define data access controls and security measures.
- Ensure compliance with data protection regulations.
- Document protocols for data storage and retention.
- List software and equipment needed for validation.
- Assess existing resources and identify gaps.
- Acquire necessary tools and ensure they are functional.
- Document all resources and their purposes.
- Gather feedback from past validation experiences.
- Identify successes and areas for improvement.
- Integrate lessons into planning and processes.
- Document insights for future reference.
- Define procedures for requesting changes.
- Establish criteria for evaluating change requests.
- Document approved changes and their impacts.
- Communicate changes to all stakeholders promptly.
- Identify types of evidence required for validation.
- Establish processes for collecting and storing evidence.
- Ensure evidence is traceable and retrievable.
- Document evidence management procedures.
- Define clear acceptance criteria for validation.
- Determine metrics for measuring success.
- Ensure criteria align with objectives and regulatory standards.
- Document criteria for stakeholder approval.
- Set intervals for progress reviews with stakeholders.
- Document findings and action items from reviews.
- Adjust plans based on review outcomes.
- Ensure consistent communication during checkpoints.
Use in Manifestly