In March 2023, FDA released a draft guidance on Part 11 Application to Clinical Investigations.  The specific introduction in the guidance stated: This document provides guidance to sponsors, clinical investigators, institutional review boards(IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations...Read More

Oct 22, 2013 press release from the office of Conressman Marsha Blackburn:”Congressman Marsha Blackburn (R-TN07) joined Representatives Gene Green (D-TX29), Dr. Phil Gingrey (R-GA11), Diana DeGette (D-CO01), Greg Walden (R-OR02), and G. K. Butterfield (D-NC01) today in introducing the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act to provide regulatory clarity regarding mobile...Read More

/docs/FDA-eSourceDataGuidance.pdfRead More

The link provided is to the Official US Government Web Site for the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs. The terms EHR and Electronic Medical Record(EMR) are sometimes used interchangeably. The issue of what systems FDA does now or might in the future regulate as a medical device is not addressed via...Read More

At the October AAMI Software Validation Course the FDA instructor indicated that the device center is not participating in this and that the Drug center’s intent is to gather information on how companies handle electronic records and signatures and not to ramp up enforcement of Part 11.Read More

This topic contains selected references for electronic records and signatures compliance. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to paid subscribers on request if...Read More

/Docs/FDA-IOMerecordssection2007.pdfRead More

/docs/Part11AdvaMednov82006finalA.pdfRead More

http://www.21cfrpart11.com/pages/sol_prov/solution_providers.htmRead More

http://www.fda.gov/ohrms/dockets/dockets/04p0429/04p-0429-let0001-vol1.pdfRead More

/docs/Part11meetingnoticeJune2004-04-7942.pdfRead More

/docs/JFamulare-Part11Advamedsllides102303.pdfRead More

/docs/Part11FinalGuidance0803.pdfRead More

/docs/MurrayPart11PresentationFoodSafetySummitMarch2003.PDFRead More

/docs/Part11esigmaintdraftguidance090502.pdfRead More

/docs/FDAPart11DraftArchivingGuidance00d-1539-nad0001.pdfRead More

http://www.fda.gov/oc/guidance/gmp.htmlRead More

http://www.fda.gov/ohrms/dockets/dockets/00d1538/00d1538.htmRead More

/docs/NEMAPart11DraftValidationGuidanceComments.pdfRead More

http://www.21cfrpart11.com/pages/sol_prov/solution_providers.htmRead More

/Docs/Part11forbiomedfocus07-01CNelsonPres.PDFRead More

/Docs/Part11pres-Kusinitz.PDFRead More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 21 CFR Part 11 Electronic Records and Electronic Signatures is a short rule with a lengthy and informative preamble.  The attached training aid provides section of the rule side by side with relevant excerpts of the preamble with some...Read More

/docs/ASQBiomedicalDivisionPart11comments.PDFRead More

/docs/PDAtechreport32.PDFRead More

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/docs/Linweldpart11wl.PDFRead More

/Docs/FDApresentationonPart11ANDClinicalTrialsSW.pdfRead More

/Docs/ORAPart11CPG.pdfRead More

/Docs/faq011299motisepresentation.pdfRead More

/Docs/esignatureswithpreamble.pdfRead More