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2018 - Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Date2018-12-04

Deadline2018-12-04

VenuePalo Alto, USA - United States USA - United States

KeywordsSoftware V&V documentation; 21 CFR Part 11 ER ES; Software V&V template

Websitehttps://www.complianceonline.com/draftin...

Topics/Call fo Papers

Major industry failures
Tougher FDA expectations / requirements
Roles of verification and validation
The 11-element FDA model - and where it's required
A typical software V&V protocol / test report
A brief overview of 21 CFR Part 11, ER / ES
Legacy, hybrid, new, and cloud systems
Expected regulatory deliverables
Complementary guidelines, e.g., GAMP

Last modified: 2018-10-27 16:30:28