|
" Electronic record keeping : "
David Nettleton, Janet Gough.
| Document Type
|
:
|
BL
|
| Record Number
|
:
|
1020743
|
| Doc. No
|
:
|
b775113
|
| Main Entry
|
:
|
Nettleton, David,1963-
|
| Title & Author
|
:
|
Electronic record keeping : : achieving and maintaining compliance with 21 CFR part 11 and 45 CFR parts 160, 162, and 164 /\ David Nettleton, Janet Gough.
|
| Publication Statement
|
:
|
Boca Raton :: Interpharm/CRC,, ©2004.
|
| Page. NO
|
:
|
1 online resource (371 pages)
|
| ISBN
|
:
|
0203485599
|
|
|
:
|
: 0849321646
|
|
|
:
|
: 9780203485590
|
|
|
:
|
: 9780849321641
|
| Bibliographies/Indexes
|
:
|
Includes bibliographical references (pages 357-358) and index.
|
| Contents
|
:
|
ELECTRONIC RECORD KEEPING: THE BIG PICTURE -- Regulatory Evolution -- The Electronic Revolution -- Compliance Requirements -- General Basis for Electronic Records -- Security, Data Transfer, Operation Checks, Archiving, and Audit Trails -- THE REGULATIONS: NOT JUST WHAT THEY SAY, BUT WHAT THEY MEAN -- 21 CFR Part 11 Electronic Records; Electronic Signatures and 45 CFR Parts 160, 162, and 164 Health Insurance Reform: Security Standards -- GOING ELECTRONIC: WHAT YOU NEED TO KNOW AND DO -- Software Development and Use: From Then Till Now -- The COTS Software Development Life Cycle -- Purchasing COTS Software -- Developer and User Validation -- Operating Environments -- IQ/OQ/PQ and CSV -- Retrospective Validation -- DOCUMENTATION AND TRAINING -- The Validation Packet -- Validation Documents -- System Support Documents -- Additional Records -- Training -- SECURITY, ACCOUNTABILITY, AND CHANGE MANAGEMENT -- Managing the System -- Security and the People Factor -- Ongoing Communication -- Managing Passwords: A Keychain -- Biometric Keychains -- Change Management -- AUDITING ELECTRONIC RECORD KEEPING SYSTEMS -- Establishing an Audit Function -- Establishing the Scope of the Audit and preparing to Audit -- Reviewing Binding Regulations and Documentation -- Planning the Audit -- Conducting the Actual Audit -- Evaluating and Reporting Results -- Keeping the Audit Function Vital -- Auditing and the Regulatory Inspection -- MOVING FORWARD -- Computer System Validation Committee -- Changing Company Cultures -- Gap Analysis -- Computer System Inventory -- Remaining Vigilant -- FREQUENTLY ASKED QUESTIONS -- Binding Regulations -- Software Vendors -- Computer System Validation -- Electronic Records -- Electronic Signatures and Accountability -- Security -- Systems -- Audit Trails -- Staying Informed.
|
| Subject
|
:
|
Medical records-- Automation.
|
| Subject
|
:
|
Medical records-- Data processing.
|
| Subject
|
:
|
Medical records-- Law and legislation-- United States.
|
| Subject
|
:
|
COMPUTERS-- Electronic Publishing.
|
| Subject
|
:
|
Medical records-- Automation.
|
| Subject
|
:
|
Medical records-- Data processing.
|
| Subject
|
:
|
Medical records-- Law and legislation.
|
| Subject
|
:
|
Medical Records-- legislation jurisprudence.
|
| Subject
|
:
|
United States.
|
| Dewey Classification
|
:
|
070.5/797
|
| LC Classification
|
:
|
KF3827.R4N48 2004eb
|
| NLM classification
|
:
|
2004 B-791
|
|
|
:
|
W 32.5AA1 N476e 2004
|
| Added Entry
|
:
|
Gough, Janet.
|
| |