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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 |