Links
• 21 CFR 820.180: [ Ссылка ]

• ISO 13485:2016 Sections 4.2.5: [ Ссылка ]

• Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 1
o Tasks 8
o Annex 4

• 21 CFR Part 11: [ Ссылка ]

• 6 Document Control Best Practices for FDA and CGMP Compliance, ISO Tracker: [ Ссылка ]

• Avoid FDA Warning Letters with These 4 Document Control Best Practices, ETQ, Feb 16th, 2019: [ Ссылка ]

Requirement name and location
Our requirement, Records, comes directly from 820.180 and 13485 Section 4.2.5.

Records in 5 words:
Maintain Records Showing 820 Compliance

свернуть