Chapter 4.8 Validation

Question 1

What is the purpose of the Validation Process?

Answer 1

Provide objective evidence the services provided comply with the stakeholders requirements in its intended operational environment
Assesses and confirms the stakeholders’ requirements correctly defined. Where variances are verified they are recorded and guide corrective actions

Question 2

What are the inputs to the Validation Process?

Answer 2

The project baseline as specified during the Stakeholder requirements Definition

The project baseline documented during Verification and Transition

Question 3

What validation documents are contained the project baseline

Answer 3

Concept Documents
Stakeholder requirements
Validation critieria

Question 4

What validation documents are contained in the project baseline documented during Verification and Transition processes

Answer 4

Final RVTM
Installed System
Transition Report

Question 5

What are the controls and enablers of the Validation Process?

Answer 5

Applicable Laws & Regulations
Industry Standards
Agreements
Project Procedures and Standards
Project Directives
Organization/Enterprise policies, procedures and standards
Organizational/Enterprise infrastructure
Project infrastructure
Validation Enabling Systems (test facilities, test equipment)

Question 6

What are the outputs of the Validation Process?

Answer 6

Validation Strategy
Validation Enabling System Requirements
Validation constraints on design
Validation procedure
Validated system
Validation report

Question 7

What two process activities comprise the Validation Process?

Answer 7

Plan Validation (develop strategy)
Perform Validation

Question 8

What activities are a part of “Perform Validation”?

Answer 8

Develop validation procedures demonstrating system is fit for its purpose and satisfies the stakeholders’ requirements
Ensure readiness to conduct validation - system, enabling systems, trained operators
Support in-process validation throughout system development
Conduct validation demonstrating conformance
Detect anomalies
Recommend corrective actions and obtain stakeholder acceptance of validation results
Document validation results and enter data into RVTM