MARC Record from marc_columbia

LEADER: 05960cam a22006851i 4500
001 16640486
005 20220716231318.0
006 m d
007 cr |||||||||||
008 200910t20212021nyua o 000 0 eng d
035 $a(OCoLC)on1222801990
035 $a(NNC)16640486
040 $aUKMGB$beng$erda$epn$cUKMGB$dOCLCO$dUKAHL$dOCLCF$dTYFRS$dYDXIT$dOCLCO
015 $aGBC0E3841$2bnb
016 7 $a019949688$2Uk
019 $a1203952612$a1222806612
020 $a9781000223033$qelectronic publication
020 $a1000223035$qelectronic publication
020 $a9781000222999$qelectronic book
020 $a1000222993$qelectronic book
020 $a9781000223019$qMobipocket electronic book
020 $a1000223019$qMobipocket electronic book
020 $a9781003105695$qelectronic book
020 $a1003105696$qelectronic book
020 $z9780367616052$qhardcover
020 $z9780367616038$qpaperback
024 7 $a10.4324/9781003105695$2doi
035 $a(OCoLC)1222801990$z(OCoLC)1203952612$z(OCoLC)1222806612
037 $a9781000223033$bIngram Content Group
037 $a9781003105695$bTaylor & Francis
050 4 $aR864$b.L67 2021
072 7 $aBUS$x070170$2bisacsh
072 7 $aBUS$x083000$2bisacsh
072 7 $aCOM$x051430$2bisacsh
072 7 $aUTF$2bicssc
082 04 $a610.285$223
049 $aZCUA
100 1 $aLópez, Orlando,$eauthor.
245 10 $aEnsuring the integrity of electronic health records :$bthe best practices for e-records compliance /$cOrlando Lopez.
264 1 $aBoca Raton, FL :$bRoultedge,$c2021.
264 4 $c©2021
300 $a1 online resource :$billustrations (black and white)
336 $atext$2rdacontent
337 $acomputer$2rdamedia
338 $aonline resource$2rdacarrier
505 0 $a1 Introduction -- 2 E-records Lifecycle Revisited -- 3 Data and E-records Lifecycles -- A Comparison -- 4 MHRA Guidance -- Revisited -- 5 E-records Integrity Expectations of EU GMP Inspectors -- 6 Comparison of Health Authorities E-records -- Integrity Expectations -- 7 Maxims of E-records Integrity -- 8 Vulnerabilities of E-records -- 9 CGMP E-records Risk Management -- 10 CGMP E-records Risk Assessments -- 11 Security Service -- 12 Defining and Managing Manufacturing Data -- 13 Controls on Transient Data -- 14 Digital Date and Timestamps -- 15 E-records Migration and Its Integrity -- 16 Ensuring E-records Integrity of Cloud Service -- Providers -- 17 E-records Integrity in Hybrid Systems -- 18 Technologies Supporting E-records Integrity -- 19 Integration Between Computer Systems and -- E-records Lifecycles -- 20 Miscellaneous E-records Integrity Issues -- 21 E-records Remediation Project Revisited -- Medicine -- Manufacturing -- 22 Designing E-records Integrity into your Practices -- 23 Introduction to Data Quality -- 24 Summary
520 $aData integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient's electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
545 0 $aOrlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence. He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies. Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications. He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation and has written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/ Familiar with gap assessment, remediation planning and remediation execution activities.
588 $aDescription based on online resource; title from digital title page (viewed on March 11, 2021).
650 0 $aMedical records$xData processing.
650 0 $aData integrity.
650 6 $aDossiers médicaux$xInformatique.
650 6 $aIntégrité des données.
650 7 $aBUSINESS & ECONOMICS / Information Management$2bisacsh
650 7 $aData integrity.$2fast$0(OCoLC)fst01746571
650 7 $aMedical records$xData processing.$2fast$0(OCoLC)fst01014552
655 4 $aElectronic books.
776 08 $iPrint version:$z9780367616052
856 40 $uhttp://www.columbia.edu/cgi-bin/cul/resolve?clio16640486$zTaylor & Francis eBooks
852 8 $blweb$hEBOOKS