Video: Freezerworks and the FDA

Recordings available from the 2010 Freezerworks Users Meeting.

Dataworks Development has been following FDA guidelines for software development and validation since their inception in 1987.  This recording is a presentation on the subject, delivered at the 2010 Freezerworks Users Meeting.  Dataworks VP for Quality Assurance and Regulatory Monitor Shannon Murray discusses the relationship between software design, validation, implementation and FDA guidelines and regulations.  

Part 1 (30 minutes) Topics include:

  • Can software be compliant?
  • What is the difference between an FDA Guideline and a Regulation?
  • How should you build quality into your systems?
  • What are predicate rules, regulations and guidelines: how do they interact, and how do they differ?
  • What should you know about 21 CFR Part 11 and how to comply with it?
  • What is the difference between software development and system development and what are your responsibilities?
  • Everything you have wanted to know about the Dataworks system for software development, including the Software Development Lifecycle, black box and white box testing, functional and design specs, and more

Part 2  (37 minutes) Topics include:

  • What should you look for when qualifying a software vendor?
  • How do you evaluate a software vendor from a business perspective? A technical perspective?
  • What is the difference between verification and validation?
  • Where does Dataworks’ validation stop and yours begin?
  • What does the FDA expect from you when you validate software?
  • Why is it important to differentiate between requirements and specifications?
  • How much testing do you have to do when Freezerworks is updated? Upgraded?