VIV Podcast

The 6 Most Common Problems in FDA Software Validation and Verification


As the industry becomes more technologically advanced, working to become fully digitized, implementing IoT strategies, including automation, machine learning and big data analytics, we are reminded that increased use of software and computerized systems also means increased risk of exposure. During this episode we covered…

  • An explanation of what CSV entails and why it’s so important in highly regulated industries…
  • Understanding 21 CFR Part 11 regulation and guidance, and the confusion it often creates for many companies…
  • 6 Common Problems:
  1.  - required systems
  2.  - software requirements
  3.  - other resources that can be insufficient or inappropriate
  4.  - vendor responsibilities
  5.  - Traceability is a HUGE factor in terms of FDA expectations during audits
  6.  – the lack of appropriate SOPs

Closing thoughts and tips…

I want everyone in our industry to know that SaaS is about convenience. It is not cheaper, and it doesn’t change your responsibilities, which is primarily CSV. Beware of vendor claims.

We all need to get smarter about computers and applications. Knowing how to shop at Amazon or watch Netflix is nothing like knowing how a GxP system works. The best users today are called knowledge workers. They take the time to seek out the industry standards and learn how to perform CSV and as a results are more valuable employees with higher pay and more opportunities.

Templates and Tools –

David Nettleton, and co-author Janet Clough, recently released a new technical book Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. With  the purchase of this useful guide you will also receive access to templates the authors have used as training tools for more than 1,000 companies and as components in more than 300 validation projects.

David is also the author of the following books which can be purchased through the PDA bookstore, or by clicking the links below:

Download the Transcript


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