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 — $397
Who Will Benefit
Quality assurance managers
Regulatory affairs officers
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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