Computer System Validation Procedures

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Computer System Validation Procedures

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Procedure Title	Purpose	Comments
Validation Requirements for Computer Systems	To define high-level requirements for the validation of different types computer systems	This procedure lays out the big picture for computer system validation. It is the link between the overall validation policy and specifics for different types of computer systems
Lifecycle for the Selection, Implementation, Validation and Use of Off-the-Shelf Computer Systems	To define the requirements and process for the development, selection, validation and use of computer systems with the purposes of assuring quality and complying with regulations.	This is the main procedure for the control of computer systems. It includes the entire lifecycle from planning to retirement. The deliverables from the lifecycle form the validation record.
Requirements for Computer System Validation Plans, Protocols and Reports	To describe the content requirements for computer system validation plans, protocols, and reports, including the validation plan for a system, the DQ, IQ, OQ and PQ validation protocols, protocol reports and the final validation report.	None.
Change Control for Validated Systems	To define the procedure for making changes to validated systems.	None.
Computer System Project Proposal	To provide a computer system project proposal form and instructions for its completion.	The computer system project proposal is completed by the system owner with input from validation & IT. It is the basis for determining if Part 11 applies to a new system, and the risks and cost associated with the system. The proposal is approved to allow the project to proceed.
Vendor Qualification and Management	To define the process for qualifying hardware and software vendors of systems that can impact the quality of products, for the annual review of vendor performance and for addressing performance issues.	The scope of this procedure does not include the qualification and management of vendors for custom software or system integration. The procedure can be used with a formal vendor corrective action system.
Vendor audit checklist	To provide a form for conducting an audit of a software vendor.	None.
Validation of Spreadsheets	To provide a process for the validation of spreadsheets.	This procedure applies the lifecycle in VAL002 to the validation of spreadsheets. A separate procedure is written for spreadsheets in order to simplify & clarify the application of the lifecycle.
Protocol Amendment Reports	To provide a form for amending a validation protocol.	None.
Protocol Variance Reports	To provide a form for recording and resolving variances that occur during the execution of a protocol.	A variance is any difference between actual results and expected results. The differences can be due to protocol or system errors.
Writing a Validation Plan	To describe the content of a validation plan and responsibilities for creating it.	This work instruction provides more detail than is given in VAL003.
Code Review Criteria	To define the process for and the criteria to be used in reviewing code for adequate documentation.	None.
Creating User and Administrative Procedures for Software Applications	To provide requirements for user and administrative procedures	The requirements defined in this procedure include appropriate Part 11 procedural requirements
Guidance - Items to Evaluate in an IQ, OQ, and PQ for a Computer System	To provide guidance on what to test in the IQ, OQ, and PQ protocols.	None.
Guidance - Suggested Approaches to Validation Lifecycle Activities Based of System Risk	To provide guidance on the performance of lifecycle activities based on the risk level of the system	The document includes guidance for off-the-shelf, configurable and custom software