Computer Software Assurance (CSA) Part 4

Computer Software Assurance (CSA) Part 4

Ilias Christodoulopoulos Ilias Christodoulopoulos

Ilias Christodoulopoulos

Quality Management, Computer Software Validation and Assurance, Data Integrity, GxP audits in the life sciences

发布日期: 2023年1月31日
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In the three earlier CSA-related articles, we listed the three recent guidelines related to CSA (CSA - Part 1), and presented a summary of our review of the regulations and guidelines related to Computer Software Assurance (CSA – Part 2). In (CSA - Part 3) we provided the detailed historical review of CSA-related regulations and we also traced CSA concepts to earlier applicable regulations and guidelines.?

In this 4th article of this series (CSA - Part 4), we examine some of the areas in which Computerized System Validation (CSV) is evolving into the Computer Software Assurance (CSA) approach in the regulated life sciences. Read more here

Dimitris H.

Foreign Direct Investment / International Expansions / MENA

2 年

Very informative and eye opening.

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