| Comment Record |
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Commentor |
Dr. Celso Bianco |
Date/Time |
2001-12-24 15:22:57 |
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Organization |
America's Blood Centers |
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Category |
Association |
| Comments for FDA General |
| Questions |
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1. General Comments
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RE: [Docket No. 00D-1538]
Draft Guidance for Industry; Electronic Records; Electronic Signatures, Validation.
America's Blood Center's, which represents nonprofit blood centers that provide approximately half of the US blood supply from volunteer donors, appreciates this opportunity to comment on the draft Guidance for Industry 21 CFR Part 11: Electronic Records; Electronic Signatures Validation.
We commend the Center for Biologics Evaluation and Research for developing a clear and concise guidance that is easy to follow and understand. The extensive list of references supplied with this document will make it much easier for users to find additional information that is pertinent. In addition, the references to the Internet support its use as a communication mode, and are extremely valuable.
We have only one specific comment:
Section 5.6. Extent of Validation. We would appreciate additional detail in the area of risk analysis. Representative examples would be particularly helpful.
Once again, thank you for the opportunity to comment. If you have any questions, please don't hesitate to contact me.
Yours truly,
Celso Bianco, MD
Executive Vice President
America's Blood Centers
Tel: (202) 393-5725, ext. 2914
E-Mail: cbianco@americasblood.org
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