Migrating, Archiving, and Reconstructing Electronic Records in a Regulatory Environment

被引：0
|
作者：
Tammala D. Woodrum
机构：
[1] Corporate Compliance,
[2] Genentech,undefined
来源：
Drug information journal : DIJ / Drug Information Association | 2001年 / 35卷 / 1期
关键词：
Electronic record; Migrate; Archive; Reconstruct;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Information technology and quality assurance professionals in various Food and Drug Administration-regulated industries are seeking advice on how to maintain electronic records and associated computerized systems in compliance with 21 CFR 11. System and record maintenance activities have raised issues with respect to: Migrating electronic records to new systems, archiving electronic records, and reconstructing electronic records in the event of a fraud investigation. Professional societies and industry groups have continued to discuss these issues since 21 CFR 11 was released in its final form in March 1997. This article has been written to present a summarization of some of those discussions.
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页码：95 / 98
页数：3
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