Скачать или смотреть Process Validation – Proven Acceptable Range 820.75 & ISO 13485 § 7.5.6 (Executive Series #74)

Links
• GHTF Quality Management Systems - Process Validation Guidance: http://www.imdrf.org/docs/ghtf/final/...

• 21 CFR 820.75: https://www.accessdata.fda.gov/script...

• ISO 13485:2016: https://www.iso.org/standard/59752.html

• Medical Device Single Audit Program (MDSAP) Audit Approach: https://www.fda.gov/media/87544/download
o Chapter 3: Task 7
o Chapter 6: Tasks 5, 7, 8, 9, 11, 13 & 15

• Questions and answers: Improving the understanding of NORs, PARs, DSp and normal variability of process parameters: https://www.ema.europa.eu/en/document...

• Design Space Considerations, By Sharmista Chatterjee: https://www.fda.gov/media/85336/download

Requirement name and location
Our topic, Proven Acceptable Range, or the PAR, is used to fulfill the requirements of Process Validation, which come directly from 820.75 and 13485 Section 7.5.6.

Proven Acceptable Range in 5 words:
Entire Data Supported Operating Window