Рет қаралды 1,167
Links
• GHTF Quality Management Systems - Process Validation Guidance: www.imdrf.org/d...
• 21 CFR 820.75: www.accessdata...
• ISO 13485:2016: www.iso.org/st...
• Medical Device Single Audit Program (MDSAP) Audit Approach: www.fda.gov/me...
o Chapter 3: Task 7
o Chapter 6: Tasks 5, 7, 8, 9, 11, 13 & 15
Requirement name and location
Our topic, Master Validation Plan, is used to fulfill the requirements of Process Validation, which come directly from 820.75 and 13485 Section 7.5.6.
Master Validation Plans in 5 words:
List All Processes Validation Status