Turner, Gareth,

Electronic SOPs vs. paper compliance with FDA CFR 21 part 11 / [electronic resource] : Electronic SOPs versus paper Electronic standard operating procedures versus paper Gareth Turner. - London : Henry Stewart Talks, 2013. - 1 online resource (1 streaming video file (41 min.) : color, sound). - SOPs for regulatory applications for the pharmaceutical industry, 2056-452X . - Henry Stewart talks. Biomedical & life sciences collection. SOPs for regulatory applications for the pharmaceutical industry. .

Animated audio-visual presentation with synchronized narration. Title from title frames.

Contents: Before technology -- From paper to technology -- EDMS development -- EDMS functionality -- Functionality and CFR 21 -- Record retention -- Electronic signatures.

Access restricted to subscribers.


Mode of access: World Wide Web.

3415 Henry Stewart Talks


United States. Food and Drug Administration.


Computer security--Standards.
Electronic information resources--Management.
Pharmaceutical industry--Documentation--Standards.
Pharmaceutical industry--Law and legislation--United States.
Pharmaceutical industry--Records and correspondence.
Computer Security--standards.
Database Management Systems.
Documentation.
Drug industry--legislation & jurisprudence.
Drug Industry--methods.
Drug industry--records & correspondence.
Guideline Adherence--legislation & jurisprudence--United States.
Information Management--standards.
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