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computer system validation deliverables

Validation Planning and Documentation

Define the scope and objectives of the computer system validation (CSV) project

Develop a validation plan outlining the approach, responsibilities, and timeline

Prepare a validation master plan (VMP) to provide an overview of the entire validation process

Document all CSV procedures and policies

User Requirements

Gather and document user requirements for the computer system

Ensure requirements are complete, accurate, and traceable

Obtain approval from relevant stakeholders for the user requirements specification (URS)

Functional Requirements

Identify and document functional requirements of the computer system

Define system behavior, features, and capabilities

Obtain approval from relevant stakeholders for the functional requirements specification (FRS)

Design and Configuration

Develop a detailed design specification for the computer system

Document hardware, software, network, and security configurations

Obtain approval from relevant stakeholders for the design specification

Installation and Qualification

Prepare an installation qualification (IQ) protocol detailing the installation process

Perform IQ testing to ensure the computer system is correctly installed

Document and address any deviations or discrepancies found during IQ testing

Operational Qualification

Develop an operational qualification (OQ) protocol to test system functionality

Execute OQ tests to verify that the system operates as intended

Resolve any issues or deviations identified during OQ testing

Performance Qualification

Create a performance qualification (PQ) protocol to evaluate system performance

Conduct PQ tests to assess system performance under expected conditions

Address any performance-related issues or deviations discovered during PQ testing

Validation Summary Report

Prepare a validation summary report (VSR) summarizing the validation activities

Include a detailed assessment of the system's compliance with requirements

Obtain approval from relevant stakeholders for the VSR

Training and Documentation

Develop training materials and provide training to system users

Ensure all relevant documentation, including user manuals and standard operating procedures, is up to date and accessible

Confirm that all system users have completed the necessary training

Change Control and Maintenance

Establish a change control process to manage any modifications to the validated system

Implement a maintenance plan to ensure ongoing system reliability and performance

Document and address any changes or maintenance activities in accordance with CSV procedures

Periodic Review and Revalidation

Conduct periodic reviews of the system to ensure continued compliance with regulations and user requirements

Determine the need for revalidation based on changes to the system or regulatory requirements

Initiate revalidation activities as necessary to maintain the system's validated state

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