评估应进一步涵盖资源，包括人员、厂房、设备和仪器、公用设施、质量控制、文件、计算机化系统、确认与验证以及废弃物管理。

4.5. The assessment to determine feasibility and readiness for technologytransfer may include technical, business, regulatory and legal aspects.

确定技术转移的可行性和准备情况的评估可能包括技术、商业、监管和法律方面。

5. Organization and management

组织和管理

5.1. All technology transfer activities should be organized andplanned.

所有技术转移活动均应得到组织和计划。

5.2. There should be a formal agreement between the parties whichspecifies the responsibilities of each party before, during and after transfer.The agreement should cover, for example, data management, data integrity,documentation and validation.

双方之间应有一份正式协议，具体规定双方在转移之前、期间和之后的责任。协议应包括，例如，数据管理，数据完整性，文件记录和验证。

5.3. All the necessary activities to be executed during thetechnology transfer project should be identified, organized and documented atthe start of the project. Responsibilities should be defined.

在技术转移项目开始时，应确定、组织和记录技术转让项目期间执行的所有必要活动。应该定义责任。

5.4. The SU should provide the necessary documentation relating tothe process, product or procedure to be transferred.