5.2.16 Control of design changes Estimated reading: 1 minute 1646 views Authors Purpose and goal It must be specified how the need for changes or modifications to the procedures is identified and documented, how a revision is initiated, when the procedure is reviewed and how the procedure is checked and approved by authorised personnel before it is used in ongoing operations. Application Description of the process Risks Resources Material Time required Documentation Responsibility and qualification Notes and comments Applicable documents Validation documents Terms Attachments 5.2.16 Control of design changes - Previous 5.2.15 Introduction of new or modified products Next - 5.2.16 Control of design changes 5.2.17 Verification of laboratory methods