Installation Qualification 820.75 & ISO 13485 § 7.5.6 (Executive Series #67)

Описание к видео Installation Qualification 820.75 & ISO 13485 § 7.5.6 (Executive Series #67)

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

Our topic, Installation Qualification, is covered by 820.75 and 13485 Section 7.5.6. For more detailed information on process validation and Installation Qualification go to the GHTF document.

Process Validation in 5 words:
Install, Check, & Start Equipment

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