Software Verification and Validation and 11 "Must Have" Documents

John E. Lincoln
From: Oct 26, 2022 - To: Dec 31, 2022
Recorded Webinar


Software and related hardware design, development, verification, and validation are difficult to manage, document and control. This presentation focuses on the verification and validation planning and execution of software, after basic developmental testing and debugging. It includes COTS (commercial off-the-shelf)  and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, and implemented, with V&V documentation and test case examples. The focus is 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 / 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.

Areas Covered:-

  • Master Verification &Validation Planning
  • V&V: Device, Test/Production Lab Equipment, Facilities / QMS
  • "Working Definition"
  • Requirements and Test Cases
  • DQ, IQ, OQ, and PQs
  • Software / Firmware V&V
  • The 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
  •  Cybersecurity

Why Should You Attend:-

Software design and development is under increased scrutiny by a "tougher" U.S. FDA. Software V&V issues, including cybersecurity, are becoming a growing area of concern for 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 under budget and within project timelines.

Who Should Attend:-

  • Senior management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • Engineering, R&D, and software development and testing teams

All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products and production/test equipment that are software-driven, companies with quality management / MRP / ERP systems moving toward "paperless" systems, or other regulated medical products / CGMP and ISO QMS activities.

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