Implementing an 11-Step Plan for Device Software Validation and Verification, 2016 Edition

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Implementing an 11-Step Plan for
Device Software Validation and Verification
2016 Edition

ISO 13485:2016 affects many different aspects of your business.

What impact will ISO 13485:2016 have on software validation and verification in addition to CGMP regulations, Part 11, ICH Q9, GAMP 4/5 already in place?

This updated edition of Implementing an 11-Step Plan for Device Software Validation and Verification contains a new chapter outlining the software validation requirements in ISO 13485:2016, including:

  • Ensuring the approach and activities for software validation or revalidation are proportionate to the risk associated with the software’s use; and
  • Maintaining records of actions taken as a result of the validation.

The report will help you interpret and apply all the rules and standards you must follow and show you how to set up an 11-step plan for device software validation and verification:

  • Perform risk analysis
  • Determine level of concern
  • Describe the software
  • Formulate requirements specifications
  • Develop design specifications
  • Create an architecture design chart
  • Craft a software development environment summary document
  • Document validation and verification testing
  • Perform a traceability analysis
  • Determine unresolved anomalies
  • Maintain a log of revision and release numbers

You'll also find out what the FDA accepts as an appropriate documentation model … the agency’s expectation for your testing software, ERP software and more … and, when and how to use design qualification, installation qualification, operational qualification and performance qualification.

With Implementing an 11-Step Plan for Device Software Validation and Verification, 2016 Edition, you'll gain a clear understanding of what the FDA and international bodies are looking for NOW.

 

PDF Edition

Available Format

PDF Edition — $397

Who Will Benefit

  • Quality assurance managers
  • Regulatory affairs officers
  • Software developers
  • Software programmers
  • Documentation specialists
  • Software testers
  • R&D managers
  • Engineers
  • Production managers
  • Operations managers

Meet the Author

This report is largely based on information provided during a recent FDAnews webinar led by John Lincoln, a principal with J.E. Lincoln and Associates. Mr. Lincoln has nearly 20 years of experience as an FDA consultant.

He has previously held positions in manufacturing, engineering, QA, QAE and regulatory affairs, as well as director of R&D. Mr. Lincoln also writes a regular column for the Journal of Validation Technology.

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