Links
21 CFR Part 11: [ Ссылка ]

ISO 13485:2016 § 4.2.5, 4.1.6: [ Ссылка ]

Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 1: Task 8
o Chapter 3: Task 7
o Chapter 6: Tasks 7, 15
o Annex 4

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, Electronic Records Electronic Signatures, comes directly from Part 11 and 13485 Section 4.1.6.

Electronic Records Electronic Signatures in 5 words:
Validate Signature & Record Systems

свернуть