Signing electronic documents
We are preparing for an inspection, which will be next week on Thursday. (FDA Mock). Which point of the regulation states that electronic documents do not need to be signed? Is it allowed to use the Google Suit system at a medical device manufacturer? (Data stored in the cloud. If not which rule can I refer to.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
In the TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A – GENERAL, Part 11 Electronic records, electronic signatures is stated that c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.
For more information, see:
- CFR - Code of Federal Regulations Title 21 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1
- Part 11, Electronic Records; Electronic Signatures - Scope and Application https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application#iiic
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Feb 09, 2021