5.2.16 Control of design changes Estimated reading: 1 minute 29 views Authors Purpose and goal Specify how the need for changes or modifications to procedures is identified and documented, how a revision is initiated, when the procedure is reviewed and how the procedure is reviewed and approved by authorized personnel prior to use in ongoing operations. Application Description of the procedure Risks Resources Material Time required Documentation Responsibility and qualification Notes and comments Applicable documents Validation documents Terms Attachments 5.2 Analysis and validation - Previous 5.2.15 Introduction of new or modified products Next - 5.2 Analysis and validation 5.2.17 Verification of laboratory methods