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008 190125s2019 ilu sb 001 0 eng d;

010 a| 2019003748;

020 a| 9780873899871q| (hardcover : alk. paper);

035 a| (WaSeSS)ssj0002310131;

042 a| pcc;

049 a| EREEa| NEHH;

050 00 a| RS122.2b| .R63 2019;

060 10 a| QV 771;

082 00 a| 615.102852| 23;

100 1 a| Rodr©Ưguez P©♭rez, Jos©♭,d| 1961-?| UNAUTHORIZED;

245 10 a| Data integrity and complianceh| [electronic resource] :b| a primer for medical product manufacturers /c| Jose Rodr©Ưguez-P©♭rez, PhD.;

260 a| Milwaukee, Wisconsin :b| ASQ Quality Press,c| [2019];

300 a| xx, 253 pages ;c| 24 cm;

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| Available only to authorized users.;

538 a| Mode of access: World Wide Web;

650 12 a| Pharmaceutical Preparationsx| standards=| ^A964325;

650 22 a| Computer Securityx| standards=| ^A1204560;

650 22 a| Equipment and Suppliesx| standards=| ^A923321;

650 22 a| Quality Control=| ^A919265;

650 22 a| Drug Industryx| standards=| ^A919097;

650 22 a| Data Accuracy=| ^A1318506;

651 2 a| United States=| ^A965939;

655 0 a| Electronic books.=| ^A491897;

710 2 a| American Society for Quality.=| ^A635949;

856 40 z| Full text available from Knovel, Academic, General Engineering & Project Administrationu| https://go.openathens.net/redirector/ecu.edu?url=https%3A%2F%2Fapp.knovel.com%2Fweb%2Ftoc.v%2Fcid%3AkpDICAPMP9%2FviewerType%3Atoc%2Froot_slug%3Adata-integrity-compliance%3Fkpromoter%3Dfederation;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=6262214;

949 a| CLICK ON WEB ADDRESSw| ASISh| JOYNER188;

949 a| CLICK ON WEB ADDRESSw| ASISh| HSL77;

949 a| CLICK ON WEB ADDRESSw| ASISh| JMUSIC60;

596 a| 1 3 4;

998 a| 5531886;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 5531886-1001l| JNETm| JOYNERr| Ys| Yt| JNESSBKu| 11/13/2020x| EBOOKz| JERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 5531886-2001l| HSLELECm| HSLr| Ys| Yt| HEBKu| 11/13/2020x| EBOOKz| HERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 5531886-3001l| MNETm| JMUSICr| Ys| Yt| MNESSBKu| 11/13/2020x| EBOOKz| JERESOURCE;

Author/creator	Rodr©Ưguez P©♭rez, Jos©♭, 1961-
Other author	American Society for Quality.
Format	Electronic
Publication Info	Milwaukee, Wisconsin : ASQ Quality Press, [2019]
Description	xx, 253 pages ; 24 cm
Supplemental Content	Full text available from Knovel, Academic, General Engineering & Project Administration
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	Pharmaceutical Preparations--standards. Computer Security--standards. Equipment and Supplies--standards. Quality Control Drug Industry--standards. Data Accuracy United States

Contents	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.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2019003748
ISBN	9780873899871 (hardcover : alk. paper)

Availability

Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Online Content Full text available from Knovel, Academic, General Engineering & Project Administration Full text available from Ebook Central - Academic Complete	✔ Available

Data integrity and compliance a primer for medical product manufacturers / Jose Rodr©Ưguez-P©♭rez, PhD.

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