FDA近年来特别关注对数据完整性的审查，国内企业要紧跟形势，认识数据完整性的重要性并完善。如某企业通过内部审查发现所有的单机版的QC数据存在用手动光盘刻录，工作量大，且无法做到实时备份；并且数据的防删除设置，使用Windows自带的进行设置；存在磁盘空间不足，产生大量的临时文件等缺陷。因此，企业进行风险评估后对原有系统实现升级，逐步将岛津、安捷伦、梅特勒等仪器产生的实验室数据连入服务器，解决数据完整性方面存在的问题。运用风险评估的理念，从URS，DQ、IQ、OQ、PQ、运行维护到到报废及退役全过程进行生命周期管理实践[1,4]。%FDA review of data integrity Special attention in recent years, domestic enterprises to closely follow the situation, understand the importance of data integrity and perfection. If an enterprise through the internal review found that all manually in the stand-alone version of the QC data CD burning, heavy workload, and does not do real-time backups and data deletion-proof, using Windows built-in set there is not enough disk space, produces a lot of temporary files, and other defects. Therefore, conduct a risk assessment of the original system upgrades, and gradually the Shimazu, Agilent, and laboratory data of the instrument connected to the server such as Mettler, resolving data integrity problems. Using the concept of risk assessment, through URS,DQ, and IQ, OQ, PQ, operation and maintenance to the scrapping and decommissioning process life-cycle management practices.
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