Biomedical Engineering Reference
In-Depth Information
necessary to perform their assigned tasks . . . We
recommend that computer education, training, and
experience be documented.
Neither a guidance nor a recommendation constitutes a
predicate rule.
23. Offi ce of Compliance, CDER, “Guidance for Industry;
Part 11, Electronic Records; Electronic Signatures -
Scope and Application,” Washington, DC: FDA (August
2003), note 8. On the choice between electronic, paper-
based, and hybrid record-keeping systems, see Rakesh
Shukla (2004). See also Dan Riordan (2007), who
echoes the fi rst predicate rules on page 33:
The FDA requires that medical device manufacturers
and pharmaceutical companies give their employees
adequate training in their job responsibilities, and in
their roles in ensuring the quality of a company's
goods and services.
Riordan continues with a list of software functions:
In compliance software systems, users can create
documentation for training requirements, job
descriptions, qualifi cation defi nitions, courses, work
instructions, and many other criteria. System
administrators can confi gure multiple levels of secure
access, so that all employee records remain confi dential.
Many systems have capabilities for managing and
tracking employee certifi cations, scheduling courses
and training sessions, and monitoring employee
performance. Approved changes to documentation
can automatically update employee training records
and simultaneously notify appropriate employees and
