MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02815cam a2200409Mi 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
on1305845639 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20240726104850.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
220319s2022 nyu o 000 0 eng d |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
EBLCP |
| Language of cataloging |
eng |
| Description conventions |
rda |
| Transcribing agency |
EBLCP |
| Modifying agency |
NT |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781685077266 |
| Qualifying information |
|
| 050 04 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RM301 |
| Item number |
.E743 2022 |
| 049 ## - LOCAL HOLDINGS (OCLC) |
|---|
| Holding library |
MAIN |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
López, Orlando, |
| Relator term |
Author |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
E-records integrity requirements /Orlando López. |
| 246 3# - VARYING FORM OF TITLE |
|---|
| Title proper/short title |
Requirements of e-Records Integrity |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
New York : |
| Name of publisher, distributor, etc. |
Nova Science Publishers, |
| Date of publication, distribution, etc. |
(c)2022. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
1 online resource (330 pages). |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS |
|---|
| File type |
data file |
| Source |
rda |
| 490 1# - SERIES STATEMENT |
|---|
| Series statement |
Research methodology and data analysis |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc. note |
Includes bibliographies and index. |
| 520 0# - SUMMARY, ETC. |
|---|
| Summary, etc. |
"The worldwide medicines' manufacturing practices regulations depend heavily on reliable data and records. The information properly recorded is the basis for manufacturers to assure the regulatory authorities of product identity, strengths, purity, and safety. The collected electronic records (e-records) also demonstrate that the manufacturing process adheres to the CGMP, including instructions. An element of reliable records is the integrity of such records. For the relevant stakeholders, such unauthorized alterations will be catalogued that the system is without the proper data integrity (DI) controls and would be deemed a noticeable deficiency. As a state or condition, e-records integrity is a measure of the validity and fidelity of related data. Based on the Universal Electronic Records Management (ERM) Requirements, Version 2.03 published by the National Archives and Records Administration (NARA), this book covers the requirements applicable to DI in the medicines' manufacturing practices regulations, pharmaceutical and biotechnological. This book presents the bounded characterization of e-records handling systems. The reader will have a reference of over fifty-three requirements that need to be agreed upon between the relevant stakeholders."-- |
| Assigning source |
|
| 530 ## - COPYRIGHT INFORMATION: |
|---|
| COPYRIGHT INFORMATION |
COPYRIGHT NOT covered - Click this link to request copyright permission: |
| Uniform Resource Identifier |
<a href="b">b</a> |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Pharmaceutical industry |
| General subdivision |
Standards. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Drug development |
| General subdivision |
Standards. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Electronic records. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Information storage and retrieval systems |
| General subdivision |
Medicine. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Information storage and retrieval systems |
| General subdivision |
Pharmacology. |
| 655 #1 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Electronic Books. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| -- |
Click to access digital title | log in using your CIU ID number and my.ciu.edu password. |
| Uniform Resource Identifier |
<a href="httpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=3186404&site=eds-live&custid=s3260518">httpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=3186404&site=eds-live&custid=s3260518</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Online Book (LOGIN USING YOUR MY CIU LOGIN AND PASSWORD) |
| DONATED BY: |
|
| VENDOR |
EBSCO |
| Classification part |
RM. |
| PUBLICATION YEAR |
2022 |
| LOCATION |
ONLINE |
| REQUESTED BY: |
|
| -- |
|
| -- |
NFIC |
| Source of classification or shelving scheme |
|
| 994 ## - |
|---|
| -- |
92 |
| -- |
NT |
| 902 ## - LOCAL DATA ELEMENT B, LDB (RLIN) |
|---|
| a |
1 |
| b |
Cynthia Snell |
| c |
1 |
| d |
Cynthia Snell |