GP 2.6 Manage Configurations Place designated work products of the validation process under appropriate levels of configuration management. Elaboration | Examples of work products placed under configuration management include the following: Lists of products and product components selected for validation Validation methods, procedures, and criteria Validation reports |
GP 2.7 Identify and Involve Relevant Stakeholders Identify and involve the relevant stakeholders of the validation process as planned. Elaboration Select relevant stakeholders from customers, end users, developers, producers, testers, suppliers, marketers, maintainers, disposal personnel, and others who may be affected by, or may affect, the product as well as the process. | Examples of activities for stakeholder involvement include the following: Selecting the products and product components to be validated Establishing the validation methods, procedures, and criteria Reviewing results of product and product-component validation and resolving issues Resolving issues with the customers or end users |
Issues with the customers or end users are resolved particularly when there are significant deviations from their baseline needs for the following: Waivers on the contract or agreement (what, when, and for which products, services, or manufactured products) Additional in-depth studies, trials, tests, or evaluations Possible changes in the contracts or agreements GP 2.8 Monitor and Control the Process Monitor and control the validation process against the plan for performing the process and take appropriate corrective action. Elaboration | Examples of measures used in monitoring and controlling include the following: Number of validation activities completed (planned versus actual) Validation problem report trends (e.g., number written and number closed) Validation problem report aging (i.e., how long each problem report has been open) |
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