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  FDA-Regulated Software Discussion Board
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SW5: Defect Management
What methods are in use for defect tracking, management, and analysis? How do we find defect tracking benefits our software development or maintenance effort? What challenges have we had to address, to ensure that defects are recorded and tracked effectively? 		0 0
SW1: Software Development Process
Idea sharing on methods that actually work for defining requirements, filling in architecture / design, and documenting everything to regulated standards. 		0 0
SW8: Metrics
What statistics do we track in our development and/or validation projects? Have we found these statistics useful? How often have new projects started out by looking back at measurements taken in previous ones? 		0 0
SW9: Risk Planning and Management
How do we approach evaluating product risk in our software projects? What do we use as our risk criteria, and as our risk levels? At what point/s in a project do we carry out the risk analysis? Which risk tools (e.g. FMEA, FTA) do we use at what points of a project, and why? How do we address risks once we've identified them? 		0 0
SW3: Reviews, Inspections and Walkthroughs
What types of outputs do we review? How do we organize and manage reviews? Are they formal and involve a team, or do we employ buddy-style "desk checks"? Which items do we review by what method, and why? What metrics do we, or can we, keep on the number of issues found and corrected in such reviews? 		0 0
SW7: Software Project Management
Everything wanted to know - or would be willing to share - about managing software development and/or validation projects in an FDA-regulated setting. 		0 0
SW10: Standards and Regulations
Which published standards or regulations apply to our specific business areas? Which ones do we feel have been useful, and which needed a lot of interpretation before they actually helped us decide what needs to be done? What do we wish were better explained or specified in the standards we need to follow? 		0 0
SW4: Configuration Management
Besides code, what outputs do we maintain under configuration management? How do we knit our configuration management together with builds, releases, and defect tracking? What configuration management "horror stories" can we tell, and how did we fix the issue? 		0 0
SW11: Favorite Tools
Comparing notes on tools for configuration management, bug tracking, requirements management, test automation, and others. 		0 0
SW6: Testing
What works and doesn't for testing - how you design it, approve the tests, review the results, and track progress 		0 0
SW2: Software Documentation
How do we document our projects? What amount of detail do we include in the documents, and how do we capture it? What procedures / SOPs do we find we need, based on how software figures in our organizations? 		0 0
 Board Statistics
Total Categories: 4 Total Forums: 26 Total Threads: 24 Total Posts: 38


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