CSA:无事生非?

IF 0.8 4区化学 Q4 SPECTROSCOPY

Spectroscopy Pub Date : 2023-04-01 DOI:10.56530/spectroscopy.hm6969t6

R. Mcdowall

引用次数: 1

摘要

计算机化系统验证(CSV)在良好实践(GxP)规范的实验室中被指控要花很长时间，并且要生成成堆的文件来让检查员和审计员保持沉默。FDA关于计算机软件保证(CSA)的指导草案可以帮助解决这个问题。但是…这是真的吗?

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

CSA: Much Ado About Nothing?

Computerized system validation (CSV) in good practice (GxP)-regulated laboratories is alleged to take ages and generate piles of paper to keep inspectors and auditors quiet. To the rescue is the draft FDA guidance on computer software assurance (CSA). But...is this really the case?

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Spectroscopy 物理-光谱学

CiteScore

1.10

自引率

0.00%

发文量

审稿时长

3 months

期刊介绍： Spectroscopy welcomes manuscripts that describe techniques and applications of all forms of spectroscopy and that are of immediate interest to users in industry, academia, and government.