Data integrity and compliance : a primer for medical product manufacturers

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Bibliographic Details
Main Author: Rodríguez Pérez, José, 1961- (Author)
Format: eBook
Language: English
Published: Milwaukee, Wisconsin : ASQ Quality Press, [2019]
Subjects:
Drugs > Standards > United States.
Computer security > Standards > United States.
Pharmaceutical industry > Standards > United States.
Quality control.
elektronické knihy
electronic books
ISBN: 9781951058470
195105847X
9780873899871
0873899873
Physical Description: 1 online resource (xx, 253 pages)

Cover

Table of contents

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003 OCoLC
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006 m o d
007 cr cn|||||||||
008 200626s2019 ilu ob 001 0 eng d
040 |a N$T  |b eng  |e rda  |e pn  |c N$T  |d OCLCO  |d N$T  |d YDX  |d EBLCP  |d OCLCF  |d OCLCA  |d OCLCO  |d OCLCQ  |d OCLCO  |d OCL  |d UKAHL  |d OCLCQ  |d OCLCO  |d OCLCL 
020 |a 9781951058470  |q (electronic bk.) 
020 |a 195105847X  |q (electronic bk.) 
020 |z 9780873899871 
020 |z 0873899873 
035 |a (OCoLC)1159982754 
043 |a n-us--- 
100 1 |a Rodríguez Pérez, José,  |d 1961-  |e author.  |1 https://id.oclc.org/worldcat/entity/E39PCjt3G7XRYTqgVbkCqMHdw3 
245 1 0 |a Data integrity and compliance :  |b a primer for medical product manufacturers /  |c Jose Rodríguez-Pérez, PhD. 
264 1 |a Milwaukee, Wisconsin :  |b ASQ Quality Press,  |c [2019] 
300 |a 1 online resource (xx, 253 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
504 |a Includes bibliographical references and index. 
505 0 |a Data integrity and good documentation practices -- ALCOA : expectations and examples -- Regulatory expectations -- Regulatory enforcement -- Data life-cycle -- Integrating data integrity into the quality system -- Clinical data integrity -- Preventing data integrity problems -- Data governance and data integrity audit -- Good documentation practices and data integrity training -- Investigating and disclosing data integrity issues -- Data integrity for outsourced activities -- Maintaining integrity of electronic data. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Drugs  |x Standards  |z United States. 
650 0 |a Computer security  |x Standards  |z United States. 
650 0 |a Pharmaceutical industry  |x Standards  |z United States. 
650 0 |a Quality control. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
710 2 |a American Society for Quality,  |e issuing body. 
776 0 8 |i Print version:  |a Rodríguez Pérez, José, 1961-  |t Data integrity and compliance.  |d Milwaukee, Wisconsin : ASQ Quality Press, [2019]  |z 9780873899871  |w (DLC) 2019003748  |w (OCoLC)1083701363 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpDICAPMP9/data-integrity-and?kpromoter=marc  |y Full text 

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