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Electronic SOPs vs. paper : compliance with FDA CFR 21 part 11 / Gareth Turner.
- Format:
- Video
- Author/Creator:
- Turner, Gareth (Director of Process Optimisation and Management, PAREXEL Consulting, Inc., UK), Speaker.
- Series:
- Henry Stewart talks. Biomedical & life sciences collection. SOPs for regulatory applications for the pharmaceutical industry.
- SOPs for regulatory applications for the pharmaceutical industry, 2056-452X
- Language:
- English
- Subjects (All):
- United States. Food and Drug Administration.
- United States.
- Computer security--Standards.
- Computer security.
- Electronic information resources--Management.
- Electronic information resources.
- Pharmaceutical industry--Documentation--Standards.
- Pharmaceutical industry.
- 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.
- Management.
- Information Management--standards.
- Medical Subjects:
- 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.
- Genre:
- Video recordings.
- Physical Description:
- 1 online resource (1 streaming video file (41 min.)) : color, sound.
- polychrome
- Other Title:
- Electronic SOPs versus paper
- Electronic standard operating procedures versus paper
- Place of Publication:
- London : Henry Stewart Talks, 2013.
- System Details:
- Mode of access: World Wide Web.
- video file
- Contents:
- Contents: Before technology
- From paper to technology
- EDMS development
- EDMS functionality
- Functionality and CFR 21
- Record retention
- Electronic signatures.
- Notes:
- Animated audio-visual presentation with synchronized narration.
- Title from title frames.
- Publisher Number:
- 3415 Henry Stewart Talks
- Access Restriction:
- Restricted for use by site license.
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