Source: https://www.softwarecpr.com/tag/electronicrecords/
Timestamp: 2020-01-23 23:30:46
Document Index: 88875735

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art11', 'art 11', 'art11', 'art 11', 'art 11', 'art11', 'art11', 'art 11', 'art11', 'art 11', 'art11', 'art 11', 'art 11', 'art 11', 'art11', 'art 11', 'art11', 'art 11', 'art 11', 'art 11', 'art11', 'art 11', 'art11', 'art 11', 'art11', 'art11', 'art 11', 'art11']

electronicrecords Archives - SoftwareCPR
US Congress Bill for Medical software Oversight
October 26, 2013Alan KusinitzNews
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...
FDA Final Electronic Source Data Guidance
September 14, 2013Alan KusinitzNews
/docs/FDA-eSourceDataGuidance.pdf
FDA CDER Part 11 Assessment Initiative
October 14, 2010Alan KusinitzNews
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.
21 CFR Part 11 Selected References
December 22, 2008Alan KusinitzNews
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...
FDA ORA IOM Electronic Records Guidance 2008
October 22, 2007Alan KusinitzNews
/Docs/FDA-IOMerecordssection2007.pdf
November 16, 2006Alan KusinitzNews
/docs/Part11AdvaMednov82006finalA.pdf
Nugenesis web page Part 11 solutions/consultants
November 7, 2005Alan KusinitzNews
http://www.21cfrpart11.com/pages/sol_prov/solution_providers.htm
FDA Responds to Petition to Withdraw Part 11
April 4, 2005Alan KusinitzNews
http://www.fda.gov/ohrms/dockets/dockets/04p0429/04p-0429-let0001-vol1.pdf
2004 FDA Announces Part 11 Public Meeting June 11
April 9, 2004Alan KusinitzNews
/docs/Part11meetingnoticeJune2004-04-7942.pdf
October 27, 2003Alan KusinitzNews
/docs/JFamulare-Part11Advamedsllides102303.pdf
FDA Final Part 11 Scope and Application Guidance
September 3, 2003Alan KusinitzNews
/docs/Part11FinalGuidance0803.pdf
Part 11 Maintenance of Electronic Recs. Guidance
September 5, 2002Alan KusinitzNews
/docs/Part11esigmaintdraftguidance090502.pdf
FDA Part 11 Committee Changes
August 27, 2002Alan KusinitzNews
http://www.fda.gov/oc/guidance/gmp.html
Docket: Industry Comments Part 11 Draft Guidances
August 13, 2002Alan KusinitzNews
http://www.fda.gov/ohrms/dockets/dockets/00d1538/00d1538.htm
NEMA comments on FDA Draft Part 11 Guidance
June 13, 2002Alan KusinitzNews
/docs/NEMAPart11DraftValidationGuidanceComments.pdf
Part 11 Software and Solutions Providers
November 16, 2001Alan KusinitzNews
June 29, 2001Alan KusinitzNews
/Docs/Part11pres-Kusinitz.PDF
Part 11 Side by Side Preamble and Rule$
September 4, 2000Alan KusinitzBlog, Prem
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...
ASQ Prepares Comments on Part 11
May 11, 2000Alan KusinitzNews
/docs/ASQBiomedicalDivisionPart11comments.PDF
February 5, 2000Alan KusinitzNews
/docs/PDAtechreport32.PDF
2nd FDA video conference on Part 11
October 21, 1999Alan KusinitzNews
/docs/Part11videotape1099.PDF
Extensive Part 11 Erecs;esig Warning Letter
August 2, 1999Alan KusinitzNews
/docs/Linweldpart11wl.PDF
Presentation by Stan Woolen of FDA
May 27, 1999Alan KusinitzNews
/Docs/FDApresentationonPart11ANDClinicalTrialsSW.pdf
Part 11 Compliance Policy Guide
May 13, 1999Alan KusinitzNews
/Docs/ORAPart11CPG.pdf
January 2, 1999Alan KusinitzNews
/Docs/faq011299motisepresentation.pdf