Computer Software Assurance

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This training session will help viewers to understand the draft guideline requirements for computer software assurance and further will provide you clarity about General Principles of Software Validation guidelines by the FDA and 21 CFR parts 820.70 and 820.72 for medical devices.
During this session, the viewers will learn about how to assure computer software practically.
The training contents are detailed below;
Brief introduction of the topic and scope
Know your Trainer
Regulatory Expectations
Draft Guideline Recommendation
Expectations from 21 CFR part 820
General Principles of Software Validation - FDA
Computer Software Assurance Risk Framework
Identifying the Intended Use
Determining the Risk-Based Approach
Determining the Appropriate Assurance Activities
Establishing the Appropriate Record
Q&A session

[@ashishyadav-jb3po]

Thank you so much sir.. For your guidance

[@hitendrakumarshah3718]

Welcome

[@rajathathireddy3285]

Hi sir, You have mentioned that we need to perform CSV for any application, then a separate document required for CSA.
Separate document means it's like a checklist kind of document whether all the CSA requirements are fulfilled or not we need to check?

[@hitendrakumarshah3718]

It is not just checklist

[@kiirannvarala87]

Good evening sir please share FDA guideline link of CSV Other than Gamp

[@hitendrakumarshah3718]

You can go through the link - www.fda.gov/files/medical%20devices/published/General-Principles-of-Software-Validation---Final-Guidance-for-Industry-and-FDA-Staff.pdf

[@kirankumarreddyavula1089]

Good evening sir

[@hitendrakumarshah3718]

Good Evening dear. Sorry for the late reply..

[@Gnanadevaj.s-eg5gy]

Please share link to refere guidlines

[@hitendrakumarshah3718]

Which guideline link you need. So that, i can share with you

[@ndgmailcom]

Good evening sir

[@hitendrakumarshah3718]

Good Evening dear. Sorry for the late reply..