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Determining The Risk Based Approach
TOPIC: CSA Risk Framework - Generally, the risk-based approach entails systematically identifying reasonably foreseeable software failures, determining whether such a failure poses a high process risk, and systematically selecting and performing assurance activities commensurate with the medical device or process risk, as applicable.
Key Steps in The CAPA Process
TOPIC: General Topics: CAPA Identification: The CAPA process begins with the identification of issues or non-conformities. This can be done through customer complaints, internal audits, product...
Computer Software Assurance - Risk Framework
The CSA guidance is intended to help manufacturers establish a risk-based framework for computer software assurance throughout the software’s lifecycle. The guidance includes an appendix of examples of applying this risk framework to various computer software assurance situations.
The Dangers of CAPA Backlogs
On September 13, 2022, the FDA issued the CSA draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
Computer Software Assurance (CSA) - What is It?
On September 13, 2022, the FDA issued the CSA draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
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