XiltriX
Back to the library
Library

GMP & compliance

What GMP, Annex 1, ISO and 21 CFR Part 11 expect from monitored data, and how to keep an audit trail that holds up years after the event.

Key questions

  • What does GMP Annex 1 mean for environmental monitoring?
  • What is required for data integrity and audit trail?
  • What does 21 CFR Part 11 require from a monitoring system?
  • What is the difference between calibration and validation?
  • How do I prove an excursion was handled correctly?
Ask about validation documentation
Narrow it down
20 items
fallback