Why Should You Attend:
Software design and development is under increased scrutiny by a "tougher" U.S. FDA. Software V&V issues are becoming a growing area of concern by regulatory agencies. 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, demanding a product risk-based approach. What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V is necessary to minimize software failures in the field or in-house? Use the FDA's own "model" to document all types of SW V&V. And use this model to add predictability to bring software V&V in under budget and within project timelines..
Areas Covered in the Webinar:
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
Software design and development is under increased scrutiny by a "tougher" U.S. FDA. Software V&V issues are becoming a growing area of concern by regulatory agencies. 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, demanding a product risk-based approach. What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V is necessary to minimize software failures in the field or in-house? Use the FDA's own "model" to document all types of SW V&V. And use this model to add predictability to bring software V&V in under budget and within project timelines..
Areas Covered in the Webinar:
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
