Computer System Validation Basic Documentation Package

• The purpose of IT policy is to define the company's requirements for the management and use of computer systems. The requirements are developed to ensure regulatory compliance, the reliability, and security of communication and computing systems, and the integrity of electronic records.
• Provide a short statement of the purpose, followed by a reference to the procedure that specifies the requirements for the validation plan .
• The purpose of this Installation Qualification (IQ) is to verify for system.
• This protocol provides documented evidence that the [system name] performs as described in the User Requirements specification. This protocol tests/verifies [specify].
• This protocol provides documented evidence that the [system name] performs in a production environment per requirements. This protocol is compliant with the requirements of VAL004.
• The purpose of this validation final report is to summarize the validation process and results for the Electronic Document Control System, and to draw a conclusion as to whether or not it meets the system acceptance criteria defined in the Validation Plan (Validation Plan for the Electronic Document Control System).
• The purpose of this procedure is to define the requirements for the validation of off-the-shelf computer systems u sed for GxP activities (including production and quality systems) and/or in conjunction with FDA required quality records.
• To describe the content requirements for computer system validation plans , protocols, and reports, including the validation plan for a system, the IQ, OQ and PQ validation protocols, protocol reports and the Validation Final Report as required by VAL002 or VAL003.
• The purpose of this procedure is to describe the requirements and process for the qualification and management of vendors who provide system software, application software, computer hardware, support services, or software development or integration services as required by VAL002.
• The purpose of this work instruction is to provide an audit checklist for auditing computer system software as recommended in VAL007.

It Provides information on:

• Validation of Off-The-Shelf Computer Systems (Risk Val).
• Requirements for Computer System Requirements, Validation Plans, Protocols and Reports (Risk Val).
• Change Control for Validated Systems (Risk Val).
• Computer System Vendor Qualification and Management (Risk Val).
• Computer System Vendor Audit Checklist (Risk Val).
• IT Policy (Risk Val).
• Validation Plan Template for Single System Validations (Risk Val).
• Computer System Technical Requirements Template (Risk Val).
• Computer System IQ Template (Risk Val).
• Computer System OQ Template (Risk Val).
• Computer System PQ Template (Risk Val).
• Validation Final Report Template (Risk Val).