The template (blank) forms used for manual recordings may be created in an electronic system (Word, Excel, etc.). The corresponding master documents should be approved and controlled electronically or in paper versions. The following expectations should be considered for the template (blank) form:

用于手工记录的模板（空白）表格可以在电子系统（Word、Excel等）中创建。相应的主文件应以电子方式或纸质方式批准和控制。对模板（空白）表格应考虑以下期望。

· have a unique reference number (including version number) and include reference to corresponding SOP number

有一个独特的参考编号（包括版本号），并包括对相应SOP编号的参考

· should be stored in a manner which ensures appropriate version control

应以确保适当版本控制的方式进行存储

· if signed electronically, should use a secure e-signature

如果以电子方式签署，应使用安全的电子签章

The distribution of template records (e.g. 'blank' forms) should be controlled. The following expectations should be considered where appropriate, based on data risk and criticality:

应控制模板记录（如 "空白 "表格）的分发。应根据数据风险和关键性，酌情考虑以下预期。

· enable traceability for issuance of the blank form by using a bound logbook with numbered pages or other appropriate system. For loose leaf template forms, the distribution date, a sequential issuing number, the number of the copies distributed, the department name where the blank forms are distributed, etc. should be known

通过使用带有页码的装订记录本或其他适当的系统，使空白表格的发放具有可追溯性。对于活页模板表格，应该知道分发日期、连续的签发号码、分发的份数、分发空白表格的部门名称等。

· Distributed copies should be designed to avoid photocoping either by using a secure stamp, or by the use of paper colour code not available in the working areas or another appropriate system.

分发的副本应通过使用安全印章，或使用工作区域内没有的纸张颜色代码或其他适当的系统来避免拍照。