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Computerized system validation

Validation Project Planning and Management

Define the scope and objectives of the validation project

Establish a validation team and assign roles and responsibilities

Develop a validation plan and timeline

Allocate necessary resources and budget for the project

Establish communication channels and reporting mechanisms

User Requirements Specification (URS)

Identify and document user requirements for the computerized system

Define functional and non-functional requirements

Specify system inputs, outputs, interfaces, and business rules

Document user acceptance criteria and validation protocols

Functional Requirements Specification (FRS)

Translate user requirements into detailed functional specifications

Define system behavior, functionality, and features

Describe system workflows and processes

Document system design components and architecture

Design Qualification (DQ)

Evaluate system design against user and functional requirements

Verify that the system design is complete, accurate, and consistent

Perform risk assessments and identify potential hazards or vulnerabilities

Document any deviations or discrepancies and propose necessary corrective actions

Installation Qualification (IQ)

Ensure that the system is installed correctly in the designated environment

Verify hardware and software installation according to specifications

Validate network connectivity and system configurations

Document installation activities and record any issues or deviations

Operational Qualification (OQ)

Test the system's operational functions and performance

Validate system inputs, outputs, and data integrity

Conduct system stress tests and performance benchmarks

Document test results, deviations, and corrective actions

Performance Qualification (PQ)

Evaluate the system's performance under real-world conditions

Test system reliability, scalability, and response times

Validate system security features and access controls

Document performance test results and address any issues or gaps

User Acceptance Testing (UAT)

Involve end-users in testing the system's usability and functionality

Validate that the system meets user requirements and expectations

Document user feedback, issues, and improvement suggestions

Obtain user sign-off and approval for system deployment

Validation Report and Documentation

Compile all validation documentation and test results

Prepare a final validation report summarizing the entire process

Include all relevant supporting documentation and evidence

Archive and maintain the validation documents for future reference and audits

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