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Printable Handouts
Navigable Slide Index
- Introduction
- Speaker's CV in short
- This talk will cover
- In days gone by
- Moving with the times
- Using EDMS without CFR 21
- Paper and technology
- Reasons for investing in technology
- What to expect from your EDMS
- Paper records
- Electronic record advantages
- Now CFR 21 part 11 kicks in
- Electronic records (1)
- Electronic records (2)
- Electronic records (3)
- Electronic records (4)
- Electronic record systems
- Electronic signatures (1)
- Electronic signature background
- Electronic signatures (2)
- Digital signatures
- Biometric signatures
- Electronic records and signatures
- eSignatures & records EDMS considerations (1)
- eSignatures & records EDMS considerations (2)
- Other considerations
- A thought for the future
- Summary
Topics Covered
- Before technology
- From paper to technology
- EDMS development
- EDMS functionality
- Functionality and CFR 21
- Record retention
- Electronic signatures
Links
Series:
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Talk Citation
Turner, G. (2013, June 13). Electronic SOPs vs. paper - compliance with FDA CFR 21 part 11 [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 14, 2024, from https://doi.org/10.69645/BGLE4237.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Gareth Turner has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Electronic SOPs vs. paper - compliance with FDA CFR 21 part 11
Published on June 13, 2013
41 min