| Comment Record |
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Commentor |
Dr. Dale Malloy |
Date/Time |
2001-12-21 15:48:18 |
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Organization |
American Association of Blood Banks |
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Category |
Health Professional |
| Comments for FDA General |
| Questions |
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1. General Comments
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December 21, 2001
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. 00D-1538 Draft Guidance for Industry; Electronic Records; Electronic Signatures, Validation; Availability
Dear Docket Officer:
The American Association of Blood Banks (AABB) appreciates this opportunity to comment on the Draft Guidance for Industry 21 CFR Part 11: Electronic Records; Electronic Signatures Validation. The AABB commends the FDA on the development of this document, which is easy to follow and understand. The supporting research is thorough, and the extensive list of references supplied with this document will make it significantly easier for users to find additional information pertinent to this topic. Finally, as the issue of validation is a complicated subject, guidance delineating FDA’s intent is extremely helpful.
The AABB offers the following comments regarding specific sections of the draft guidance.
Section 5.2.1 Validation Plan
The AABB recommends that the guidance document be redrafted to place greater attention on the requirement for validation documentation. Specifically, facilities must write plans and procedures prior to commencement of the validation process. Development of a thorough validation plan and procedures in advance of the actual execution of the plan allows a facility to gain insight into the weaknesses and areas where testing of critical functions may have been omitted.
The AABB also suggests requiring a date, time stamp, and signature for the validation plan and procedures. This information could be used to verify that the validation pre-dated creation of the validation report.
The AABB recommends that the guidance require that the management representative approving the validation plan have sufficient background and understanding of the computer systems involved, as well as operational systems. For example, in a blood bank, the representative should know laboratory operations and the computer functions involved in processing laboratory data. Requiring the representative to have an understanding of computer processes and knowledge of donor recruitment, donor qualification, and component preparation will ensure that all critical functions are included in the validation plan. This same requirement should apply to the designated management representative responsible for reviewing and approving the Validation Procedures (Section 5.2.2) and the Validation Report (Section 5.2.3).
Section 5.7 Independence of Review
This section requires that computer system validation be performed by persons other than those responsible for developing the system. It is not common practice to obtain independent expert opinion on the computer validation plan. The document should be drafted in such a way to draw attention to this new requirement.
Section 5.6 Extent of Validation
The AABB recommends that additional detail be supplied in the area of risk analysis. Representative examples would be particularly helpful.
Section 6.2 The Internet
The AABB urges the FDA to retain all references to the Internet in the final version of this document. These references highlight the importance of electronic forms of communication.
The AABB thanks the FDA for the opportunity to comment on this draft guidance. If you have any questions, please contact Kay Gregory, Director Regulatory Affairs at kayg@aabb.org or (910) 842-2790.
Sincerely,
Dale Malloy, DPA, MT(ASCP)SBB
President
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