Links
21 CFR 820.70i: [ Ссылка ]
ISO 13485:2016 § 4.1.6, 7.5.6: [ Ссылка ]
Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 3: Task 7
o Chapter 6: Tasks 7, 15
AAMI TIR36:2007: [ Ссылка ]
Part 11, Electronic Records; Electronic Signatures - Scope and Application – Guidance for Industry: [ Ссылка ]
QMS Software Validation – When is it needed?, by Allan Murphy Bruun: [ Ссылка ]
GHTF Quality Management Systems – Process Validation Guidance: [ Ссылка ]
Quality System Regulation Process Validation, by Joseph Tartal: [ Ссылка ]
Requirement name and location
Our requirement, Software Validation, comes directly from 820.70i and 13485 Section 4.1.6 & 7.5.6.
Software Validation in 5 words:
Validate Software for Intended Use
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