This Validation Verification Package contains the following items for your examination:
• Software development lifecycle (SDLC) validation process
• Freezerworks modules validated in the test scripts
• Validation completion by round, spreadsheet
• Samples of completed test script pages
• Certificate of Validation
Final documentation of the test scripts, above, encompasses approximately 6000 printed pages. For ease of review, selected representative samples of pages have been provided.
- Certificate of Validation for Freezerworks Unlimited 6.0
- Certificate of Validation for Freezerworks Basic 7.0
- Freezerworks Assists with Security Standards
- Section 508 VPAT for Freezerworks and Freezerworks Unlimited
- General Principles of Software Validation: Final Guidance for Industry and FDA Staff
- 21 CFR Part 11 Compliance
- Federal Information Processing Standard (FIPS 140-2)
See our two part video on software validation, the FDA, and Freezerworks.