| Comment Record |
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Commentor |
Ms. Sharon McKilligin |
Date/Time |
2001-12-24 12:09:55 |
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Organization |
The Society of Quality Assurance |
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Category |
Association |
| Comments for FDA General |
| Questions |
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1. General Comments
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December 21, 2001
Submitted electronically
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20853
Docket Number 00D-1538, Validation
Dear Dockets Manager:
The Society of Quality Assurance's Computer Validation Initiative Committee has reviewed FDA's Draft Guidance for Industry on 21 CFR Part 11 -- Validation. We acknowledge the principles and purpose described in this guidance as key requirements in performing validation of computerized system subjected to this regulation. This is a high level document giving guidance to those individuals who must comply with this regulation. FDA has published more detailed guidance for industry and those are referenced in this document. SQA supports FDA's effort to establish a foundation of validation principles in this document while still continuing to reference other important documents on this subject.
Sincerely,
Sharon McKilligin, Chair
Society of Quality Assurance
Computer Validation Initiative Committee
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