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2019 - Software Validation and its 11 Key Documents
Date2019-04-17
Deadline2019-04-17
VenueOnline Event, USA - United States 
KeywordsSoftware validation; Validation documentation; Fda model
Topics/Call fo Papers
Major areas of industry failure
Tougher FDA Expectations / Requirements; Cybersecurity
Roles of Verification and Validation
An FDA "Model"
A Typical Software V&V Protocol / Test Report; "Black" and "White" box
A Brief Overview of 21 CFR Part 11, and its implementation
Legacy, Hybrid, New and ER / ES Systems
Expected Regulatory Deliverables
Complementary Guidelines
Tougher FDA Expectations / Requirements; Cybersecurity
Roles of Verification and Validation
An FDA "Model"
A Typical Software V&V Protocol / Test Report; "Black" and "White" box
A Brief Overview of 21 CFR Part 11, and its implementation
Legacy, Hybrid, New and ER / ES Systems
Expected Regulatory Deliverables
Complementary Guidelines
Other CFPs
Last modified: 2019-04-02 20:58:02