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Computer Software Assurance (CSA) from top-to-bottom
Computer Software Assurance (CSA) from top-to-bottom
22 SEP 2021 · CSA, short for Computer Software Assurance, is poised to make improvements on the 20-year-old Computer System Validation (CSV) practices life science organizations have been following. Is it new? Why all the hype? What is it, exactly? This episode explains how CSA is different from CSV, promising new opportunities that may be around the corner, and simply a better way to do something required by law (i.e., Validate systems).
Transcribed
29 SEP 2021 · This podcast will give you skills to evaluate, identify, and distinguish between relevant and irrelevant information. This podcast will explain how you can be a critical thinker.
For life science specifically, FDA's new Computer Software Assurance (CSA) validation methodology puts Critical Thinking at the forefront.
In general, we live in a knowledge-based society, and the more critical you think the better your knowledge will be.
Critical Thinking provides skills to analyze and evaluate information to attain the most knowledge about a subject, problem, solution, strategy, etc. Critical Thinking provides the best chance of making the correct decision while minimizing damages if a mistake is made.
Utilizing critical thinking skills leads to becoming a more rational and disciplined thinker. It reduces prejudice, bias and provides a better overall understanding of a situation.
13 OCT 2021 · CSA recommends Assurance Needs, right after Critical Thinking. What is Assurance Needs? This episode dives into this topic shedding light, based upon industry experience, on what to address in this phase of CSA validation.
20 OCT 2021 · CSA Testing is the third level tier in the upended pyramid that is poised to disrupt Computer System Validation (CSV) or at least provide a refresher for Risk-Based Validation with a Least Burdensome approach, along with different testing modalities such as ad hoc, exploratory, and automated testing. This podcast dives into Testing in CSA, along with highlighting a root cause common with poor test scripts and test steps.
28 OCT 2021 · Is "Documentation" really the focus of CSA even if it's placed at the lowest level of the pyramid? In this episode, I'll cover the last in a series dedicated to Computer Software Assurance (CSA), from Critical Thinking, Assurance Needs, Testing, and now Documentation.
Information
Author | Life Sciences Live |
Organization | Life Sciences Live |
Categories | Courses |
Website | - |
steve@inteknique.com |
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