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Books > Business & Economics > Industry & industrial studies > Media, information & communication industries > Publishing industry
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Electronic Record Keeping - Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Hardcover)
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Electronic Record Keeping - Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Hardcover)
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The current revolution in software, and the regulations that have
evolved to address it, have increasingly caused companies to turn
to off-the-shelf software for electronic record keeping. Data
captured in computerized systems must be as reliable, if not more
so, than data on paper. Electronic Record Keeping: Achieving
Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
explores how to evaluate, select, implement, and document an
e-system that will keep your organization in compliance. Covering
Title 21 of the Code of Federal Regulations (CFR) Part 11 and the
parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of
the Health Insurance Portability and Accountability Act (HIPAA),
this book provides guidance for selecting, purchasing, installing,
validating, and managing commercial off-the-shelf software for data
collection and retention. It takes a number of years for industry
standards for a new regulation to develop from dialog between
companies and the regulating agency. These standards are in place
for Part 11, which was passed into law in 1997. Healthcare
providers who must implement electronic record keeping can learn
how to best do it by understanding the parallel between the new
HIPAA regulations and the industry standards for Part 11. Further,
certain FDA-driven activities, such as patient record keeping in
clinical trials, now must comply with the new HIPAA regs as well.
To help companies achieve and maintain compliance, the authors
cover audit trails, validation, documentation, training, and
security and accountability. They discuss what the regulations say
and what they mean. Compliance may be mandatory, but it also makes
good business sense. Companies that are compliant will always be
poised to move forward, and they will avoid the grief that comes
from poor or faulty record keeping and documentation. This book
gives you the tools you need to keep your company both compliant
and competitive.
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