金币
UID176556
帖子
主题
积分25112
注册时间2014-6-6
最后登录1970-1-1
听众
性别保密
|
发表于 2018-2-8 12:56:59
|
显示全部楼层
word直接打印记录合规吗???一般都不允许使用word直接打印记录,被修改的风险极大,无法受控。除了原始记录或原始主批记录word打印后,审阅签字转化为扫描版的PDF,这样才能实现文件的受控(不仅为发放受控,还应该实现打印原件的真实性受控)
§211.68 Automatic, mechanical, and electronic equipment.
(b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained. |
|