000 04440cam a22005651i 4500
001 9781003105695
003 FlBoTFG
005 20220724194446.0
006 m d
007 cr |||||||||||
008 200910s2020 nyua o 000 0 eng d
040 _aOCoLC-P
_beng
_erda
_epn
_cOCoLC-P
020 _a9781000223033
_q(ePub ebook)
020 _a1000223035
020 _a9781000222999
_q(PDF ebook)
020 _a1000222993
020 _a9781000223019
_q(Mobipocket ebook)
020 _a1000223019
020 _a9781003105695
_q(ebook)
020 _a1003105696
020 _z9780367616052 (hbk.)
020 _z9780367616038 (pbk.)
024 7 _a10.4324/9781003105695
_2doi
035 _a(OCoLC)1222801990
_z(OCoLC)1203952612
_z(OCoLC)1222806612
035 _a(OCoLC-P)1222801990
050 4 _aR864
072 7 _aBUS
_x070170
_2bisacsh
072 7 _aBUS
_x083000
_2bisacsh
072 7 _aCOM
_x051430
_2bisacsh
072 7 _aUTF
_2bicssc
082 0 4 _a610.285
_223
100 1 _aLópez, Orlando,
_eauthor.
245 1 0 _aEnsuring the integrity of electronic health records :
_bthe best practices for e-records compliance /
_cOrlando Lopez.
250 _a1st.
264 1 _aNew York :
_bProductivity Press,
_c2020.
300 _a1 online resource :
_billustrations (black and white)
336 _atext
_2rdacontent
336 _astill image
_2rdacontent
337 _acomputer
_2rdamedia
338 _aonline resource
_2rdacarrier
505 0 _a<P>1 Introduction</P><P>2 E-records Lifecycle Revisited</P><P>3 Data and E-records Lifecycles -- A Comparison</P><P>4 MHRA Guidance -- Revisited</P><P>5 E-records Integrity Expectations of EU GMP Inspectors</P><P>6 Comparison of Health Authorities E-records</P><P>Integrity Expectations</P><P>7 Maxims of E-records Integrity</P><P>8 Vulnerabilities of E-records</P><P>9 CGMP E-records Risk Management</P><P>10 CGMP E-records Risk Assessments</P><P>11 Security Service</P><P>12 Defining and Managing Manufacturing Data</P><P>13 Controls on Transient Data</P><P>14 Digital Date and Timestamps</P><P>15 E-records Migration and Its Integrity</P><P>16 Ensuring E-records Integrity of Cloud Service</P><P>Providers</P><P>17 E-records Integrity in Hybrid Systems</P><P>18 Technologies Supporting E-records Integrity</P><P>19 Integration Between Computer Systems and</P><P>E-records Lifecycles</P><P>20 Miscellaneous E-records Integrity Issues</P><P>21 E-records Remediation Project Revisited -- Medicine</P><P>Manufacturing</P><P>22 Designing E-records Integrity into your Practices</P><P>23 Introduction to Data Quality</P><P>24 Summary</P>
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.
588 _aOCLC-licensed vendor bibliographic record.
650 0 _aMedical records
_xData processing.
650 0 _aData integrity.
650 7 _aBUSINESS & ECONOMICS / Information Management
_2bisacsh
856 4 0 _aEnsuring the integrity of electronic health records
_3Taylor & Francis
_uhttps://www.taylorfrancis.com/books/9781003105695
856 4 2 _3OCLC metadata license agreement
_uhttp://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf
942 _2lcc
_cEBK
999 _c17840
_d17840