The art of compliance is a craft much like that of a carpenter who learns to
work with various kinds of wood and designs. Ours is an industry wrought
with differences. While the regulations that govern FDA-regulated industries
are proscribed, how the regulations are interpreted and applied really
depends on experience and how well one has mastered the craft of compliance.
There are no proscribed procedures, but there are guideposts common
to all FDA-regulated industries, whether a firm manufactures medical
devices, pharmaceuticals, or biological products....
More companies are designing solutions to address data governance and ensure regulatory compliance by reducing
data movement. These companies rely on the security and auditing features of the DBMS to ensure that regulated
data is not improperly accessed during automated business processes. Requiring large amounts of detail data to be
extracted from the DBMS for processing by SAS raises the complexity of maintaining regulatory compliance. This can
be particularly challenging for data preparation processes.
Infection control in health care continues to be the subject of intensive
research and debate.
Implementing safe and realistic infection control procedures requires the
full compliance of the whole dental team. These procedures should be
regularly monitored during clinical sessions and discussed at practice
meetings. The individual practitioner must ensure that all members of the
dental team understand and practice these procedures routinely.
Every practice must have a written infection control policy, which is
tailored to the routines of the individual practice and regularly updated.
A widely cited application of sensor networks is event-
detection, where a large network of nodes is used to iden-
tify regions or resources that are experiencing some phe-
nomenon of particular concern to the user.
The NRC has adopted a risk-informed, performance-
based approach to regulation. The result is that the
procedural aspects of a licensee’s radiation protection
program are not required to constitute “best practice”
in the medical use of radionuclides, as long as perfor-
mance outcomes are in compliance. The continued
need for some of the suggested procedures in this book
should be considered in light of the licensee’s own prior
experience obtained during reviews of its radiation