Data integrity and compliance : a primer for medical product manufacturers / Jose Rodríguez-Pérez, PhD
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..
| Medienart: |
E-Book |
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| Erscheinungsjahr: |
[2019] |
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| Erschienen: |
Milwaukee, Wisconsin: ASQ Quality Press ; 2019 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rodríguez Pérez, José, 1961- [VerfasserIn] |
|---|---|
| Körperschaft: |
American Society for Quality [Herausgebendes Organ] |
| Links: |
search.ebscohost.com [lizenzpflichtig] |
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| ISBN: |
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| Anmerkungen: |
Includes bibliographical references and index |
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| Umfang: |
1 Online-Ressource (xx, 253 pages) |
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| Förderinstitution / Projekttitel: |
|
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| PPN (Katalog-ID): |
1734540702 |
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