The 11 Must-have Documents of Software Verification and Validation
Tuesday, September 17, 2013 from 10:00 AM to 11:30 AM (PDT)
Why Should You Attend:
Recently a major pharma company paid a $750 M fine for poor compliance, and software V&V was one of the key contributors.
Product, production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. A comprehensive, corporate wide plan is a necessity. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resource-intensive V&V activities, in a resource-constrained environment.
This presentation focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and growing "cloud"-based software. A suggested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus will be on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) In-product, 2) As-product, 3) Production and test, and 4) QMS / 21 CFR Pt. 11. Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.
This session will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
Areas Covered in the Webinar:
- Recent industry failures
- Tougher FDA Expectations / Requirements
- Roles of Verification and Validation
- The 11-Element FDA "Model"
- 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
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