5.2.16 Control of design changes Estimated reading: 1 minute 152 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 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
