调整与管理行业要求相关的监管活动。对员工进行监管要求培训。必须保留相应监管机构的记录，并且新产品工艺必须在向组织发布之前获得相应监管机构的批准。提交生命周期——即提交及其组件的创建、审查和批准必须以协作方式进行管理。 Aligning regulatory activities related to managing industry requirements. Train employees on regulatory requirements. Records for the appropriate regulatory agencies must be maintained and the new product process must be approved by the appropriate regulatory body before it is published to the organization. The submission lifecycle � i.e. creation, review, and approval of the submission and its components must be managed in a collaborative fashion.