Automated Process 820.70i & ISO 13485 QMS Software Validation §4.1.6, 7.5.6. (Executive Series #39) скачать в хорошем качестве

Automated Process 820.70i & ISO 13485 QMS Software Validation §4.1.6, 7.5.6. (Executive Series #39)

Links 21 CFR 820.70i: https://www.accessdata.fda.gov/script... ISO 13485:2016 § 4.1.6, 7.5.6: 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 7, 15 AAMI TIR36:2007: https://webstore.ansi.org/standards/a... Part 11, Electronic Records; Electronic Signatures - Scope and Application – Guidance for Industry: https://www.fda.gov/regulatory-inform... QMS Software Validation – When is it needed?, by Allan Murphy Bruun: https://www.simplerqms.com/qms-softwa... GHTF Quality Management Systems – Process Validation Guidance: http://www.imdrf.org/docs/ghtf/final/... Quality System Regulation Process Validation, by Joseph Tartal: https://www.fda.gov/media/94074/download 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