Biomedical Engineering Reference
In-Depth Information
Electronic Signatures,” which is Part 11 of 21 CFR). In
keeping with the emergence of electronic technologies, FDA
issued regulations in 1997 for e-records and e-signatures that
sought to permit wide use of electronic technology,
compatible with the protection of public health. Soon after
they became effective, FDA announced a reconsideration of
these regulations. In 2003, FDA withdrew the guidances that
had accompanied the regulations. While the reconsideration
of the regulations was under way, FDA indicated they would
narrowly interpret the scope of Part 11 and promised to
exercise enforcement discretion. During this period, records
and record-keeping need still comply with the underlying
regulations.
A typical example of FDA regulations and associated
record-keeping is quality complaints about regulated
products. 21 CFR 211.204 requires written procedures for
the handling of all product quality complaints. This
requirement (“predicate rule”) further stipulates that “a
written record of each complaint shall be maintained in a fi le
designated for drug product complaints.”
That is a second predicate rule; since it deals with record-
keeping, it implicates Part 11, if the organization has chosen
to manage that record electronically. Moreover, the initial
regulation also stipulates that a record shall be maintained,
should an investigation of the product complaint be
conducted; or the record shall include the reason and the
name of the person responsible for a decision not to conduct
an investigation. That is a third predicate rule; since it also
deals with maintaining records of investigations, it also
implicates Part 11.
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Equipment cleaning and maintenance under good
laboratory practice (GLP), good manufacturing practice
(GMP), and medical device regulations have broader scope
(Table 11.1). The cleaning and maintenance requirement
