Device Software Verification and Validation

Device Software Verification and Validation - Webinar CD/Transcript

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Meet the FDA’s new software investigators. They’re armed — with IT knowledge — and are cracking down on medical devicemakers whose software doesn’t measure up.

It’s a crackdown for certain on device software verification and validation. The agency has hired a cadre of sophisticated enforcers, tough new inspectors trained in IT to recognize that software validation and documentation are the foundation for the safety of any device.

The software associated with medical devices is getting closer scrutiny than ever before because of increasing prevalence in industry, greater chance for problems, and the comfort level of FDA investigators in asking for and auditing software applications.
FDAnews invited veteran FDA consultant John Lincoln to take the virtual stage to explain what the FDA expects of you now, and how to achieve it in a hurry.

In a 90-minute in-depth chalk talk, Mr. Lincoln demonstrates a preferred FDA 11-element documentation model in various applications; including ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications.

He addresses the use of FDA guidances, GAMP 4/5, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models and their real-world implementation.

You’ll come away with an actionable understanding of:

  • Developing and creating buy-in for a project validation plan
  • Understanding what the FDA accepts as an appropriate documentation model
  • Beyond just in-product software V&V — understanding FDA’s expectation for your testing software, ERP software and more
  • When and how to use DQ, IQ, OQ, PQ or their equivalents
  • How GAMP 4/5 requirements fit into your V&V planning and execution
  • Detailing the FDA’s 11 key V&V documentation elements:
    1. Level of Concern
    2. Hazard/Risk Analysis
    3. Software Description
    4. SRS (Software Requirements Specification)
    5. Architecture
    6. Design Specification
    7. Traceability (Matrix; Paragraph Numbering)
    8. Development
    9. V&V (Verification/Testing & Validation: IQ, OQ, Part 11 test cases, if required, PQs)
    10. Revision History and Release Number
    11. Unresolved Anomalies ('Bugs')
  • “White Box” and “Black Box” validations
  • And much more

Device Software Verification and Validation gives you a clear understanding of FDA inspector expectations and how to meet them, with a specific focus on software that is as-product, in-product, process and/or in overall manufacturing and operations. Why risk FDA sanctions, let alone multimillion-dollar liability lawsuits? Order your webinar CD and transcript today.

Consider getting if you are in:

  • Software development
  • Programming, documentation
  • Testing
  • QA/RA
  • R&D and engineering
  • Manufacturing production and operations

John Lincoln has nearly 20 years’ experience as an FDA consultant. As Principal of J.E. Lincoln and Associates LLC, Mr. Lincoln has worked with companies from start-ups through Fortune 100 giants, in countries from the U.S. to Taiwan. He has held positions in Manufacturing, Engineering, QA, QAE, and Regulatory Affairs as well as Director of R&D. A prolific author, he writes a regular column for the Journal of Validation Technology.