关于温度记录仪（比如无纸温度记录仪）的PART 11合规性

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各位蒲友：
关于仓库，冷库（柜）无纸温度记录仪的part 11合规性符合性问题，大家是怎么做的呢？？？谢谢！规避这种符合性的问题，大家是使用有纸打印吗（比如热敏纸），但是又说到这个问题，有纸打印也会存在更改伪造的问题（这个让我想起了相应的尘埃粒子计数器）。
• Program access has been secured and authenticated. Access privileges or permissions restrict who is allowed to set
up the equipment and use the application.
• Software reads and records hardware and firmware model, version, and serial number. Software can identify each unique piece of equipment.
• Data loggers link to an audit trail file for traceability. This is an essential requirement to show that documentation is trustworthy.
• Data loggers have been positioned in defined locations. Regulatory Note: GMPs require the use of calibrated equipment and records to show maintenance to acceptable standards. If you gathered data in electronic form, these records must meet regulations for electronic records as defined in 21 CFR Part 11, in EC Annex 11, and in European Union GMP Chapter 4. (See Regulations and Guidance for details.)