Biomedical Engineering Reference
In-Depth Information
device personnel, 21 CFR 820.25; for human tissue
recovery personnel, 21 CFR 1271.170.
18. See 21 CFR 58.29 (b), “Personnel.” As Robert
McDowell (2004) has put it “It appears that Part 11
would not apply to computerized systems holding GMP
training records, in contrast to GLP systems holding
similar records where the rules would apply.”
19. See 21 CFR 312.23(a)(6)(iii)(b). A curriculum vitae is
more a record of educational attainment than a training
history. Since the protocol is part of the IND regulatory
submission, it will implicate Part 11 on that ground.
20. See 21 CFR 211.34, “Consultants.”
21. But see Wise-Blackman, op. cit., p. S-10, who repeatedly
refers to “software that is 21 CFR Part 11 compliant
and houses a database of training records.” The software
that she advocates is not justifi ed in terms of predicate
rules - as we have seen, there are not any - but as
follows: “One benefi t of compliant training software is
the ease of routine scheduling of required training” and
“Routine retraining can be accomplished effi ciently
through the use of group sessions or individual web-
based compliant software.” Of course, “routine
scheduling” and “routine retraining” can be more easily
and effi ciently accomplished with any validated training
tracking system, regardless of its Part 11 compliance.
22. See 21 CFR 11.10 (i); see however Offi ce of the
Commissioner, “Guidance for Industry: Computerized
Systems Used in Clinical Investigations,” Washington,
DC: FDA (May 2007), p. 7:
Those who use computerized systems must determine
that individuals (e.g., employees, contractors) who
develop, maintain, or use computerized systems
have the education, training, and experience
