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Navigable Slide Index

1. Introduction
2. Speaker's CV in short
3. This talk will cover
4. In days gone by
5. Moving with the times
6. Using EDMS without CFR 21
7. Paper and technology
8. Reasons for investing in technology
9. What to expect from your EDMS
10. Paper records
11. Electronic record advantages
12. Now CFR 21 part 11 kicks in
13. Electronic records (1)
14. Electronic records (2)
15. Electronic records (3)
16. Electronic records (4)
17. Electronic record systems
18. Electronic signatures (1)
19. Electronic signature background
20. Electronic signatures (2)
21. Digital signatures
22. Biometric signatures
23. Electronic records and signatures
24. eSignatures & records EDMS considerations (1)
25. eSignatures & records EDMS considerations (2)
26. Other considerations
27. A thought for the future
28. Summary

Topics Covered

• Before technology
• From paper to technology
• EDMS development
• EDMS functionality
• Functionality and CFR 21
• Record retention
• Electronic signatures

Links

Series:

• SOPs for Regulatory Applications for the Pharmaceutical Industry

Categories:

• Methods
• Pharmaceutical Sciences

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 June 10, 2023, from https://hstalks.com/bs/2562/.
Export Citation (RIS)

Publication History

• Published on June 13, 2013

Financial Disclosures

• Mr. Gareth Turner has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.