Regulated Software and Systems: What FDA Expects to See

For the regulated software and systems you use in your activities, consult this list — prepared by former FDA investigators at EduQuest (including EduQuest President Martin Browning, the co-author of Part 11) who have done thousands of computer system audits worldwide — to make sure you’re meeting FDA’s expectations.

When they inspect regulated software and systems, FDA investigators want to see:

  • An established development process or methodology
  • A written and approved validation plan
  • Documented requirements
  • Documented functional specifications
  • Documented design specifications
  • Documented testing protocols and evidence of reviews of objective test results
  • Documented evidence of installation protocols and evidence of test results and reviews
  • A written and approved validation report
  • Complete and documented traceability (from requirements to testing)
  • Documentation of responsible approvals
  • A defined maintenance and change control process, including risk analysis
  • Documentation of changes, impact of those changes, risk assessment of those changes, and periodic monitoring
  • An effective vendor management process
  • System security

For more information and training on FDA expectations for automated systems, plan to attend EduQuest’s flagship training class, FDA Auditing of Computerized Systems and Part 11/Annex 11 ComplianceWith an Alumni of thousands, the class was originally developed to train FDA investigators to understand and inspect computerized systems and now has been presented to students in FDA-regulated companies for the past 20 years.

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